Clinical trial NCT02095691: RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
Official title: A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Renal
Keywords: Renal Sympathetic Denervation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.


Eligibility criteria: Inclusion Criteria:

1. Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines.
2. Subject 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.
3. Subject is \> 18 and \< 85 years of age.
4. Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.

Key Exclusion Criteria:

1. A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
2. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
3. Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
4. Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.
5. Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula.
6. Subject has type 1 diabetes mellitus.
7. 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.
8. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.

Primary outcomes:
measure: Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit
timeFrame: 12 months post-procedure
measure: Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
timeFrame: 12 months post-procedure
measure: Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
timeFrame: 12 months post-procedure
measure: Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
Study officials:
References: