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

NCT ID: NCT01438229

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-07-31

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

Conditions

Hypertension

Study Design

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

Study Groups

renal artery ablation

Catheter-based RF ablation in renal artery

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Catheter-based RF ablation in renal artery

Interventions

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

Intervention Type: DEVICE

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)
• Others

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vasilias Papademetriou, MD

Role: PRINCIPAL_INVESTIGATOR

First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece

Konstantinos Tsioufis, MD

Role: PRINCIPAL_INVESTIGATOR

First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece

Stephen Worthley, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Investigation Unit, Royal Adelaide Hospital, Adelaide, Australia

Ian Meredith, MD

Role: PRINCIPAL_INVESTIGATOR

Monash Medical Centre, Melbourne, Australia

Derek Chew, MD

Role: PRINCIPAL_INVESTIGATOR

Flinders Medical Centre, Adelaide, AUSTRALIA

Locations

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Adelaide, South Australia, Australia

Monash Medical Centre

Melbourne, Victoria, Australia

Hippokration Hospital

Athens, , Greece

Countries

Australia; Greece

Other Identifiers

Arsenal

Identifier Type: OTHER

Identifier Source: secondary_id

CI-10-045-ID-HT

Identifier Type: -

Identifier Source: org_study_id