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The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.
The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncontrolled hypertension patients | The study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnligHTN™ Renal Denervation System | Device | The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Office Systolic Blood Pressure at 6 Months | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure | 30 days | |
| Mean Change in Office Systolic Blood Pressure at 1 Month | Baseline and 1 month | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with uncontrolled hypertension
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| Name | Affiliation | Role |
|---|---|---|
| José Diaz, MD | Hospital Juan Ramon Jimenez, Huelva, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Civil Marie Curie | Lodelinsart | Hainaut | 6042 | Belgium | ||
| North Estonia Medical Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | Uncontrolled Hypertension Participants | Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
67 participants underwent renal denervation; 1 participant was excluded because of inclusion criteria violation
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| ID | Title | Description |
|---|---|---|
| BG000 | Uncontrolled Hypertension Participants | Renal denervation procedure with the EnligHTN System for the treatment of uncontrolled hypertension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 participant was excluded due to inclusion criteria violation |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Office Systolic Blood Pressure at 6 Months | 58 out of 67 participants analyzed for primary outcome measure of office systolic blood pressure at 6 months. | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
|
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Adverse event data were collected over 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Uncontrolled Hypertension Participants | Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Maslow, MA, Clinical Project Manager | Abbott | +1 651-756-5564 | rebecca.maslow@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2014 | Jun 18, 2019 | Prot_SAP_000.pdf |
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|
| Mean Change in Office Diastolic Blood Pressure at 1 Month |
| Baseline and 1 month |
| Mean Change in Ambulatory Systolic Blood Pressure at 1 Month | Baseline and 1 month |
| Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month | Baseline and 1 month |
| Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month | 1 month |
| Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months | Baseline and 6 months |
| Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months | Baseline and 12 months |
| Renovascular Safety at 6 Months (Renal Artery Stenosis) | Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation. | 6 months |
| Mean Change in Office Systolic Blood Pressure at 12 Months | Baseline and 12 months |
| Mean Change in Office Diastolic Blood Pressure at 6 Months | Baseline and 6 months |
| Mean Change in Office Diastolic Blood Pressure at 12 Months | Baseline and 12 months |
| Mean Change in Ambulatory Systolic Blood Pressure at 6 Months | Baseline and 6 months |
| Mean Change in Ambulatory Systolic Blood Pressure at 12 Months | Baseline and 12 months |
| Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months | Baseline and 6 months |
| Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months | Baseline and 12 months |
| Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months | 6 months |
| Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months | 12 months |
| Tallinn |
| Harjuma |
| 13419 |
| Estonia |
| Dr. Gianluigi Patelli | Alzano Lombardo | Lombardy | 24068 | Italy |
| Instituto Clinico Citta Studi | Milan | Lombardy | 20131 | Italy |
| Policlinico San Marco | Osio Sotto | Lombardy | 24040 | Italy |
| Clinica San Gaudenzio | Novara | Peimonte | 28100 | Italy |
| Hospital de Santa Cruz | Carnaxide | Lisbon District | 2795-523 | Portugal |
| Hospital Juan Ramon Jimenez | Huelva | Andalusia | 21005 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hopspital Infanta Cristina | Badajoz | 06010 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46206 | Spain |
| Hospital Xeral-Cies de Vigo | Vigo | 36204 | Spain |
| Craigavon Area Hospital | Portadown | Nirelnd | BT63 5QQ | United Kingdom |
| Withdrawal by Subject |
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| Procedurally excluded |
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| Other |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 1 participant was excluded due to inclusion criteria violation | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Physical Assessment - Weight | 1 participant was excluded due to inclusion criteria violation | Mean | Standard Deviation | kg |
|
| Physical Assessment - Height | 1 subject was excluded due to inclusion criteria violation | Mean | Standard Deviation | cm |
|
| Physical assessment - Body Mass Index (BMI) | 1 participant was excluded due to inclusion criteria violation | Mean | Standard Deviation | kg/m^2 |
|
| Hypertension (HTN) | Data were not collected for all participants. | Mean | Standard Deviation | years |
|
| Renal artery atherosclerosis | 1 participant was excluded due to inclusion criteria violation | Count of Participants | Participants |
|
| Renal artery atherosclerosis percentage | 2 participants had renal artery atherosclerosis, of which both were located on the right side. | Mean | Standard Deviation | percentage (%) |
|
| Renovascular Hypertension | 1 participant was excluded due to inclusion criteria violation | Count of Participants | Participants |
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| Other Renal Disease | 1 participant was excluded due to inclusion criteria violation | Count of Participants | Participants |
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| Cardiovascular History | 1 participant was excluded because of inclusion criteria violation. | Count of Participants | Participants |
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| Neurological history | 1 participant was excluded due to inclusion criteria violation | Count of Participants | Participants |
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| Additional Medical History | 1 participant was excluded due to inclusion criteria violation | Count of Participants | Participants |
|
| Office Blood Pressure | Data were not collected for all participants. | Mean | Standard Deviation | mmHg |
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| Ambulatory Blood Pressure | Data were not collected for all participants | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Data were not collected for all participants | Mean | Standard Deviation | bpm (beats per minute) |
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| Participants on stable anti-HTN medication prior to enrollment | 1 participant was excluded due to inclusion criteria violation | Count of Participants | Participants |
|
| Number of anti-HTN medications participant currently takes | 1 participant was excluded due to inclusion criteria violation | Mean | Standard Deviation | medications |
|
| Antiarrhythmic Medication currently being taken | Please note: Same participant may be on multiple different medications, and counted in each category. | Antihypertensive medication usage information was available for all enrolled participants | Count of Participants | Participants |
|
| Serum creatinine concentration | Data were not collected for all participants | Mean | Standard Deviation | umol/L |
|
| Estimated Glomerular Filtration Rate (eGFR) | Data were not collected for all participants | Mean | Standard Deviation | mL/min per 1.73 m^2 |
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| Urine Albumin to Creatinine Ratio | Data were not collected for all participants | Mean | Standard Deviation | mg/g |
|
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| Secondary | Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure | Posted | Count of Participants | Participants | 30 days |
|
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| Secondary | Mean Change in Office Systolic Blood Pressure at 1 Month | 61 out of 67 participants were analyzed for mean reduction in office Systolic Blood Pressure at 1 month. | Posted | Mean | Standard Deviation | mmHg | Baseline and 1 month |
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| Secondary | Mean Change in Office Diastolic Blood Pressure at 1 Month | 61 out of 67 analyzed for mean change in office Diastolic Blood Pressure at 1 month | Posted | Mean | Standard Deviation | mmHg | Baseline and 1 month |
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| Secondary | Mean Change in Ambulatory Systolic Blood Pressure at 1 Month | 23 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 1 month | Posted | Mean | Standard Deviation | mmHg | Baseline and 1 month |
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| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month | 23 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 1 month. | Posted | Mean | Standard Deviation | mmHg | Baseline and 1 month |
|
|
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| Secondary | Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month | 62 out of 67 participants analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 1 month. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months | 48 out of 67 analyzed for renal function change based on eGFR at 6 months. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Baseline and 6 months |
|
|
|
| Secondary | Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months | 38 out of 67 analyzed for renal function change based on eGFR at 12 months. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Baseline and 12 months |
|
|
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| Secondary | Renovascular Safety at 6 Months (Renal Artery Stenosis) | Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation. | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | Mean Change in Office Systolic Blood Pressure at 12 Months | 54 out of 67 participants analyzed for mean change in office Systolic Blood Pressure at 12 months. | Posted | Mean | Standard Deviation | mmHg | Baseline and 12 months |
|
|
|
| Secondary | Mean Change in Office Diastolic Blood Pressure at 6 Months | 58 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 6 months | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
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| Secondary | Mean Change in Office Diastolic Blood Pressure at 12 Months | 54 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 12 months | Posted | Mean | Standard Deviation | mmHg | Baseline and 12 months |
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| Secondary | Mean Change in Ambulatory Systolic Blood Pressure at 6 Months | 29 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 6 months | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
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| Secondary | Mean Change in Ambulatory Systolic Blood Pressure at 12 Months | 25 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 12 months | Posted | Mean | Standard Deviation | mmHg | Baseline and 12 months |
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| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months | 29 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 6 months | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
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| Secondary | Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months | 25 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 12 months | Posted | Mean | Standard Deviation | mmHg | Baseline and 12 months |
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| Secondary | Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months | 59 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 6 months | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months | 55 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 12 months | Posted | Count of Participants | Participants | 12 months |
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| Post-Hoc | Serum Creatinine Concentration at 6 Months | 55 out of 67 analyzed for serum creatinine concentration at 6 months. | Posted | Mean | Standard Deviation | umol | 6 months |
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| Post-Hoc | Serum Creatinine Concentration at 12 Months | 46 out of 67 analyzed for serum creatinine concentration at 6 months. | Posted | Mean | Standard Deviation | umol | 12 months |
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| Post-Hoc | Urine Albumin to Creatinine Ratio at 6 Months | 17 out of 67 analyzed for serum creatinine concentration at 6 months. | Posted | Mean | Standard Deviation | mg/g | 6 months |
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| Post-Hoc | Urine Albumin to Creatinine Ratio at 12 Months | 14 out of 67 analyzed for serum creatinine concentration at 6 months. | Posted | Mean | Standard Deviation | mg/g | 12 months |
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| Post-Hoc | Number of Anti-hypertensive Medications Participant Currently Takes at 12 Months | 55 out of 67 participants were analyzed for number of anti-hypertensive medications taken at 12 months | Posted | Mean | Standard Deviation | number of medications | 12 months |
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| 1 |
| 68 |
| 8 |
| 68 |
| 5 |
| 68 |
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Myocardial Ischemia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Artery Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sustained Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Viral Syndrome | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| VASC Vessel Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Arterial Hypertension/Hypertension | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Bacterial Infections of the Skin | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Drug Side Effect | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Urinary Tract Infections | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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