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Rapid Renal Sympathetic Denervation for Resistant Hypertension

NCT01520506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-03-01

Study results available
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Summary

The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Conditions

  • Hypertension, Resistant to Conventional Therapy

Interventions

DEVICE

Covidien OneShot™ System

Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • W.A.L. Tonino, MD · Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands

  • Stefan Verheye, MD · Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-11-30
Completion
2014-06-30

Countries

  • Belgium
  • Germany
  • Italy
  • Luxembourg
  • Netherlands
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520506 on ClinicalTrials.gov