Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)

February 14, 2019 updated by: Medtronic Endovascular

Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Middelheim Hospital
      • Genk, Belgium, 3600
        • Ziekenhuis Oost--Limburg
  • Germany
      • Bonn, Germany
        • Universitätklinikum
      • Frankfurt, Germany
        • Cardiovascular Center Sankt Katharinen
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Heidelberg, Germany
        • Univ. Medical Klinik III
      • Münster, Germany
        • Franziskus Hospital
  • Italy
      • Milano, Italy
        • Hospital San Raffaele
  • Luxembourg
      • Luxembourg, Luxembourg, L-1210
        • Centre Hospitalier de Luxembourg
  • Netherlands
      • Eindhoven, Netherlands
        • Santa Catharina Hospital
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus MC Thoraxcenter
      • Utrecht, Netherlands
        • UMC Universitair Medisch Centrum
  • New Zealand
      • Auckland, New Zealand
        • Mercy Angiography Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
  2. Age 18-85 years.
  3. Able to provide informed consent and comply with follow-up visits.

Exclusion Criteria:

  1. Diameter of left or right renal artery less than 4 mm or greater than 7mm.
  2. Length of target segment of left or right renal artery less than 20mm.
  3. Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
  4. End-stage renal disease requiring dialysis or renal transplant.
  5. estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m2.
  6. Type 1 diabetes mellitus.
  7. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
  8. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
  9. Bleeding disorder or refusing blood transfusions.
  10. Pregnancy or breast feeding.
  11. Peripheral vascular disease precluding catheter insertion.
  12. Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
  13. Current enrollment in another investigational drug or device Study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rapid Renal Denervation
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.
Other Names:
  • Covidien OneShot™ Renal Denervation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Procedural Safety
Time Frame: One Week

Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:

  • SAE's related to groin and vascular access complications, and
  • SAE's related to renal artery injury.
One Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Procedural Safety
Time Frame: 6 months
Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months
6 months
Renal Denervation Procedure Effectiveness
Time Frame: From baseline to 6 months
Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline
From baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Collaborators

Medtronic - MITG
Meditrial Europe Ltd.

Investigators

  • Principal Investigator: W.A.L. Tonino, MD, Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands
  • Principal Investigator: Stefan Verheye, MD, Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP 012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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