This trial is active, not recruiting.

Conditions renal denervation, hypertension
Treatments renal sympathetic denervation, celsius® thermocool® rd multi-electrode ablation catheter, celsius® thermocool® rdgw multi-electrode ablation catheter
Phase phase 1
Sponsor Biosense Webster, Inc.
Start date October 2013
End date March 2014
Trial size 19 participants
Trial identifier NCT02095691, RENABLATE-II


The RENABLATE-II study is a prospective, multi-center, non-randomized feasibility study of Catheter-Based Renal Denervation to evaluate the safety and effectiveness of the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter and Celsius® ThermoCool® RDGW Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
renal sympathetic denervation
Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter, Celsius® ThermoCool® RDGW Multi-electrode Ablation Catheter
celsius® thermocool® rd multi-electrode ablation catheter, celsius® thermocool® rdgw multi-electrode ablation catheter

Primary Outcomes

Renal Denervation Safety
time frame: 12 months

Secondary Outcomes

time frame: 6 months
time frame: 6 months
Office Blood Pressure Change
time frame: 12 months
Target Blood Pressure
time frame: 6 months
Blood Pressure Changes
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title A Prospective, Multi-center, Non Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II- 157)
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Biosense Webster, Inc..