Ablation-induced Renal Sympathetic Denervation Trial

Abbott Medical Devices4 sites in 2 countries47 target enrollmentOctober 2011

ConditionsHypertension

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hypertension
Sponsor: Abbott Medical Devices
Enrollment: 47
Locations: 4
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

July 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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)