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Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

Ablation-induced Renal Sympathetic Denervation Trial

NCT01438229•Abbott Medical Devices

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Adelaide, South Australia, Australia

Monash Medical Centre

Melbourne, Victoria, Australia

Hippokration Hospital

Athens, Greece

Key Dates

Start Date

October 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

July 1, 2014

Last Updated

February 5, 2019

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

DEVICE

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

Inclusion Criteria

Exclusion Criteria

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