RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157 (RENABLATE-II)

• ClinicalTrials.gov Identifier: NCT02095691
• Recruitment Status: Completed
• First Posted: March 26, 2014
• Results First Posted: December 7, 2015
• Last Update Posted: December 7, 2015
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension, Renal	Device: Celsius® ThermoCool® Renal Denervation	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)
• Study Start Date: October 2013
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: April 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Resistant Hypertension; The Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension.	Device: Celsius® ThermoCool® Renal Denervation; The investigational device is indicated for the treatment of resistant hypertension by renal denervation.; Other Name: Multi-electrode Ablation Catheter

Outcome Measures

Primary Outcome Measures :

1. Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure. [ Time Frame: 30 days post-procedure ]
   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 Outcome Measures :

1. Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit [ Time Frame: 12 months post-procedure ]
   These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural 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.
2. Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure [ Time Frame: 12 months post-procedure ]
   Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.
3. Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure [ Time Frame: 12 months post-procedure ]
   The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.
4. Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure [ Time Frame: 12 months post-procedure ]
   Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Czech Republic

Charles University Hospital

Prague, Czech Republic, 12808

Na Homolce Hospital

Prague, Czech Republic, 15 030

Italy

Ospedale Generale Regionale

Bari, Italy

New Zealand

Mercy Angiography

Epsom, Auckland, New Zealand

Spain

Hospital Universitari Clinic de Barcelona

Barcelona, Spain

Sponsors and Collaborators

Biosense Webster, Inc.

More Information

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT02095691
• Other Study ID Numbers: RENABLATE-II
• First Posted: March 26, 2014
• Results First Posted: December 7, 2015
• Last Update Posted: December 7, 2015
• Last Verified: October 2015

Keywords provided by Biosense Webster, Inc.:

Renal Sympathetic Denervation

Additional relevant MeSH terms:

Hypertension, Renal; Hypertension; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases