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

NCT02095691 | Completed Phase 1 Results DMC

• 1 other identifier: RENABLATE-II
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension, Renal

Keywords

Renal Sympathetic Denervation

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Events That Occurred Within 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.

  30 days post-procedure

Secondary Outcomes (4)

• Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit

  12 months post-procedure

• Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure

  12 months post-procedure

• Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure

  12 months post-procedure

• Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure

  12 months post-procedure

Study Arms (1)

Resistant Hypertension

EXPERIMENTAL

The Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension.

Device: Celsius® ThermoCool® Renal Denervation

Interventions

Celsius® ThermoCool® Renal Denervation DEVICE

The investigational device is indicated for the treatment of resistant hypertension by renal denervation.

Also known as: Multi-electrode Ablation Catheter

Resistant Hypertension

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
• Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
• Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.
• Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula.
• Subject has type 1 diabetes mellitus.
• 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.
• Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Hypertension, Renal

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Liesbeth Vanderlinden, Manager Clinical Research
• Organization: Biosense Webster, EMEA

lvanderl@its.JNJ.com

+32(0)2 7463527

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2015
• Last Updated: February 4, 2025
• Results First Posted: December 7, 2015

Record last verified: 2025-01