RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension

NCT01756300 | Completed Phase 1 Results DMC

• 1 other identifier: RENABLATE
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension, Renal

Keywords

Essential Hypertension; Renal Denervation; Vascular Disease; Renal Catheter Ablation; Primary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days post-procedure

Secondary Outcomes (5)

• Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure

  12 months post-procedure

• 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

• 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

• 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

• 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

Study Arms (1)

Resistant Hypertension

EXPERIMENTAL

The catheter-based (device: Celsius® ThermoCool® RD) renal denervation will serve to treat resistant hypertension.

Device: Celsius® ThermoCool® RD

Interventions

Celsius® ThermoCool® RD DEVICE

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.

Also known as: Multi-electrode Ablation Catheter

Resistant Hypertension

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 and \< 85 years old.
• Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
• 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.
• Individual 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:

• Subjects with known/diagnosed secondary hypertension.
• Subject has 'White Coat' hypertension defined as 24 hour daytime systolic blood pressure \<135 mm Hg as evaluated at Baseline visit.
• Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter.
• Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
• Subject has multiple main renal arteries in either kidney.
• Subject has a history of prior renal artery intervention including balloon angioplasty, stenting or surgery.
• Subject had a previous kidney transplant or is a planned recipient of a transplant kidney or is on dialysis.
• Subject has a past history of unilateral kidney removal or has a solitary functional kidney for any other reason.
• 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 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.
• Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
• Subject is taking systemic steroids or chronic daily NSAIDs.
• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Hypertension, Renal; Essential Hypertension; Vascular Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; 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: December 20, 2012
• First Posted: December 25, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2015
• Last Updated: February 4, 2025
• Results First Posted: August 25, 2015

Record last verified: 2025-01