| Primary | Adverse Events | All device or procedure related adverse events | All subjects receiving renal artery ablation procedure | Posted | | Number | | percentage of participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Office Systolic Blood Pressure Change | | Subjects with both baseline and 6M follow up office blood pressure measurements | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Office Diastolic BP Change | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6M | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Office Systolic BP Change | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 12M | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Office Systolic BP Change | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 18 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Office Systolic BP Change | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Office Diastolic BP Change | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Office Diastolic BP Change | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 18 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Office Diastolic BP Change | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | 24hr Ambulatory Systolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| |
| Other Pre-specified | 24hr Ambulatory Systolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| |
| Other Pre-specified | 24hr Ambulatory Systolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| |
| Other Pre-specified | 24hr Ambulatory Diastolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| |
| Other Pre-specified | 24hr Ambulatory Diastolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| |
| Other Pre-specified | 24hr Ambulatory Diastolic BP Change | Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded. | | Posted | | Mean | Standard Deviation | mmHg | | Baseline to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| |
| Other Pre-specified | Urine Albumin to Creatinine Ratio | | | Posted | | Mean | Standard Deviation | mg/g | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Urine Albumin to Creatinine Ratio | | | Posted | | Mean | Standard Deviation | mg/g | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Urine Albumin to Creatinine Ratio | | | Posted | | Mean | Standard Deviation | mg/g | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Urine Albumin to Creatinine Ratio | | | Posted | | Mean | Standard Deviation | mg/g | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Urine Albumin to Creatinine Ratio | | | Posted | | Mean | Standard Deviation | mg/g | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) | | Posted | | Mean | Standard Deviation | mL/min per 1.73m^2 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) | | Posted | | Mean | Standard Deviation | mL/min per 1.73m^2 | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) | | Posted | | Mean | Standard Deviation | mL/min per 1.73m^2 | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) | | Posted | | Mean | Standard Deviation | mL/min per 1.73m^2 | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Estimated Glomular Filtration Rate | Calculated using Modifide Diet in Renal Disease formula. estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) | | Posted | | Mean | Standard Deviation | mL/min per 1.73m^2 | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | |
| Other Pre-specified | Cystatin C | | | Posted | | Mean | Standard Deviation | mg/L | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Cystatin C | | | Posted | | Mean | Standard Deviation | mg/L | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Cystatin C | | | Posted | | Mean | Standard Deviation | mg/L | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Cystatin C | | | Posted | | Mean | Standard Deviation | mg/L | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
|
| Other Pre-specified | Cystatin C | | | Posted | | Mean | Standard Deviation | mg/L | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Renal Artery Ablation | Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery |
| | | Title | Denominators | Categories |
|---|
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