| Primary | Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6 months | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG002 | C - EnligHTN for Resistant HTN & CKD |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
| | | Title | Denominators | Categories |
|---|
| Baseline | | | Title | Measurements |
|---|
| - OG000179.9± 22.3
- OG001160.8± 17.9
- OG002177.1± 22.7
|
| | 6 Months |
| |
| Secondary | Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure | The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Count of Participants | | Participants | | 30 days post procedure | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months | The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months | Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Confirmatory visit to 6 months | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years | The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Count of Participants | | Participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years | The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years | Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Confirmatory visit to 2 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years | Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mL/min/1.73 m^2 | | Confirmatory visit to 5 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6 months | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6 months | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6 months | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months | The percentage of participants achieved office systolic blood pressure <140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure <140 mmHg at 6 months visit to the number of participants with data available in 6 months visit. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 1 year | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 2 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 3 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 4 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 5 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 1 year | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 2 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 3 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 4 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation | Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 5 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 | B - EnligHTN for Resistant HTN |
- Office systolic Blood Pressure ≥140 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups |
|
| Secondary | Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 1 year | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 2 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 3 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 4 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 5 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 1 year | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 2 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 3 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 4 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|
| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation | 24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value. | The number of participants analyzed includes subjects who were available at the time of analysis | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 5 years | | | | ID | Title | Description |
|---|
| OG000 | A - EnligHTN for Severe Resistant HTN |
- Office systolic Blood Pressure ≥160 mmHg
- Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
- Participant has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
EnligHTN: Renal artery ablation with EnligHTN system used for all groups | | OG001 |
|