Hypertension, Renal
Conditions
Keywords
Essential Hypertension, Renal Denervation, Vascular Disease, Renal Catheter Ablation, Primary Hypertension
Brief summary
The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to treat resistant hypertension.
Detailed description
The RENABLATE feasibility study CS156 (EC12-02) is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of renal artery sympathetic denervation using the investigational Celsius® ThermoCool® Renal Denervation (RD) Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.
Interventions
DEVICECelsius® ThermoCool® RD
The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \> 18 and \< 85 years old. 2. Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings. 3. Individual is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months. 4. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.
Exclusion criteria
1. Subjects with known/diagnosed secondary hypertension. 2. Subject has 'White Coat' hypertension defined as 24 hour daytime systolic blood pressure \<135 mm Hg as evaluated at Baseline visit. 3. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter. 4. Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter. 5. Subject has multiple main renal arteries in either kidney. 6. Subject has a history of prior renal artery intervention including balloon angioplasty, stenting or surgery. 7. Subject had a previous kidney transplant or is a planned recipient of a transplant kidney or is on dialysis. 8. Subject has a past history of unilateral kidney removal or has a solitary functional kidney for any other reason. 9. Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula. 10. Subject has type 1 diabetes mellitus. 11. Subject has history of Myocardial Infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques. 12. Subject had a significant surgery or cardiovascular intervention in the 6 months period preceding enrollment or is planned to have such a surgery or cardiac intervention in the 6 months period post enrollment. 13. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous. 14. Subject is taking systemic steroids or chronic daily NSAIDs. 15. Subject has a known allergy to Aspirin and/or other procedural drugs or contrast agents which in the investigator's opinion excludes him/her from the study. 16. Subject has a serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (e.g., subjects with active systemic infection, subjects with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia). 17. Women of childbearing potential with a positive pregnancy test during screening OR women who do not agree to remain on birth control until follow-up at 6 months OR lactating women. 18. Subject has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. 19. Subject is currently enrolled in another investigational drug or device trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure. | 30 days post-procedure | The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure | 12 months post-procedure | These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events. |
| Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | From baseline to 1 ,3, 6 and 12 months post procedure | This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline. |
| Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | From baseline to 3, 6 and 12 months post procedure | This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline. |
| Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure | At 1, 3, 6, and 12 month post-procedure | This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics). |
| Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure | At 1, 3, 6, and 12 month post-procedure | This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure |
Participant flow
Recruitment details
The study enrollment took approximately 11 months, began in December 2, 2012 and completed on November 4, 2013. A total of 68 subjects were consented and 35 started the renal denervation with the investigational ablation catheter.
Pre-assignment details
After signing the inform of consent, subjects were evaluated on inclusion/exclusion criteria, anatomic eligibility, compliant with completing the subject diary. Thirty-three subjects failed and never underwent insertion of the study ablation catheter.
Participants by arm
| Arm | Count |
|---|---|
| Renal Sympathetic Denervation Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Renal Sympathetic Denervation |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized African Descent | 0 participants |
| Race/Ethnicity, Customized Not African Descent | 35 participants |
| Region of Enrollment Australia | 15 participants |
| Region of Enrollment Belgium | 5 participants |
| Region of Enrollment Czech Republic | 12 participants |
| Region of Enrollment Denmark | 1 participants |
| Region of Enrollment Italy | 2 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 35 |
| serious Total, serious adverse events | 7 / 35 |
Outcome results
Primary
The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.
The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation.
Time frame: 30 days post-procedure
Population: The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Sympathetic Denervation | The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure. | 0.0 percentage of participants |
Secondary
Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure
This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.
Time frame: From baseline to 3, 6 and 12 months post procedure
Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Sympathetic Denervation | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 156.0 mmHg | Standard Deviation 12.9 |
| Renal Sympathetic Denervation | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | NA mmHg | — |
| Renal Sympathetic Denervation | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 85.8 mmHg | Standard Deviation 12.7 |
| Renal Sympathetic Denervation | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | NA mmHg | — |
| Blood Pressures at 1-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | -9.8 mmHg | Standard Deviation 12.7 |
| Blood Pressures at 1-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 80.8 mmHg | Standard Deviation 10.8 |
| Blood Pressures at 1-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | -3.9 mmHg | Standard Deviation 8.2 |
| Blood Pressures at 1-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 145.4 mmHg | Standard Deviation 17.2 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 78.5 mmHg | Standard Deviation 11.9 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | -13.1 mmHg | Standard Deviation 15.7 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | -6.8 mmHg | Standard Deviation 8 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 142.1 mmHg | Standard Deviation 15.6 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | -7.1 mmHg | Standard Deviation 6.7 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | -14.7 mmHg | Standard Deviation 14.9 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 141.2 mmHg | Standard Deviation 15.6 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 79.0 mmHg | Standard Deviation 11.2 |
Secondary
Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.
Time frame: From baseline to 1 ,3, 6 and 12 months post procedure
Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and radiofrequency (RF) energy is successfully applied in at least one artery. .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Sympathetic Denervation | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 95.8 mmHg | Standard Deviation 16.3 |
| Renal Sympathetic Denervation | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 171.0 mmHg | Standard Deviation 10.4 |
| Renal Sympathetic Denervation | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | NA mmHg | — |
| Renal Sympathetic Denervation | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | NA mmHg | — |
| Blood Pressures at 1-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | -10.0 mmHg | Standard Deviation 21.1 |
| Blood Pressures at 1-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 161.0 mmHg | Standard Deviation 21.1 |
| Blood Pressures at 1-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 88.3 mmHg | Standard Deviation 15 |
| Blood Pressures at 1-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | -7.6 mmHg | Standard Deviation 13.7 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 159.7 mmHg | Standard Deviation 21.7 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | -8.3 mmHg | Standard Deviation 12.4 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | -11.3 mmHg | Standard Deviation 21.9 |
| Blood Pressures at 3-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 87.5 mmHg | Standard Deviation 13 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 155.4 mmHg | Standard Deviation 15.6 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | -10.7 mmHg | Standard Deviation 13.5 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 85.0 mmHg | Standard Deviation 11.7 |
| Blood Pressures at 6-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | -15.4 mmHg | Standard Deviation 17.6 |
| Blood Pressures at 12-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Mean Change from Baseline | -9.0 mmHg | Standard Deviation 12.9 |
| Blood Pressures at 12-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Office Blood Pressure | 151.0 mmHg | Standard Deviation 18.7 |
| Blood Pressures at 12-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Systolic Mean Change from Baseline | -19.8 mmHg | Standard Deviation 20.7 |
| Blood Pressures at 12-Month Follow Up | Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure | Diastolic Office Blood Pressure | 86.4 mmHg | Standard Deviation 15.7 |
Secondary
Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure
This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure
Time frame: At 1, 3, 6, and 12 month post-procedure
Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Sympathetic Denervation | Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure | 48.1 percentage of participants |
| Blood Pressures at 1-Month Follow Up | Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure | 48.1 percentage of participants |
| Blood Pressures at 3-Month Follow Up | Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure | 61.5 percentage of participants |
| Blood Pressures at 6-Month Follow Up | Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure | 76.9 percentage of participants |
Secondary
Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure
This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).
Time frame: At 1, 3, 6, and 12 month post-procedure
Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Sympathetic Denervation | Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure | 14.8 percentage of participants |
| Blood Pressures at 1-Month Follow Up | Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure | 18.5 percentage of participants |
| Blood Pressures at 3-Month Follow Up | Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure | 15.4 percentage of participants |
| Blood Pressures at 6-Month Follow Up | Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure | 23.1 percentage of participants |
Secondary
Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure
These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.
Time frame: 12 months post-procedure
Population: The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Sympathetic Denervation | Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure | 74.3 percentage of participants |