Overview

This trial is active, not recruiting.

Condition hypertension
Treatment st. jude medical renal artery ablation system: rf ablation generator (ibi 1500t11.5) and renal artery ablation catheter (ds3d001, ds3d002)
Sponsor St. Jude Medical
Start date October 2011
End date September 2012
Trial size 47 participants
Trial identifier NCT01438229, Arsenal, CI-10-045-ID-HT

Summary

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Catheter-based RF ablation in renal artery
st. jude medical renal artery ablation system: rf ablation generator (ibi 1500t11.5) and renal artery ablation catheter (ds3d001, ds3d002)
Catheter-based RF ablation in renal artery

Primary Outcomes

Measure
All adverse events
time frame: 6 months
Office Blood Pressure
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment - Age ≥18 and ≤80 years old - Able and willing to provide written informed consent to participate in the study - Able and willing to comply with the required follow-up schedule Exclusion Criteria: - Prior renal artery intervention (balloon angioplasty or stenting) - Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery - Multiple main renal arteries in either kidney - Main renal arteries <4 mm in diameter or <20 mm in length - eGFR of <45 mL/min per 1.73 m2 using the MDRD formula - Type 1 diabetes - Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure) - Others

Additional Information

Official title Ablation-induced Renal Sympathetic Denervation Trial
Principal investigator Vasilias Papademetriou, MD
Description Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension. Safety Marker - All adverse events Efficacy Marker - Office blood pressure
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by St. Jude Medical.