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

NCT ID: NCT02095691

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resistant Hypertension

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

Group Type: EXPERIMENTAL

Celsius® ThermoCool® Renal Denervation

Intervention Type: DEVICE

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

Interventions

Celsius® ThermoCool® Renal Denervation

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

Intervention Type: DEVICE

Other Intervention Names

Multi-electrode Ablation Catheter

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RENABLATE-II

Identifier Type: -

Identifier Source: org_study_id