Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Maya Medical
Sponsor:
Collaborators:
Covidien
Meditrial SrL
Information provided by (Responsible Party):
Maya Medical
ClinicalTrials.gov Identifier:
NCT01520506
First received: January 25, 2012
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Hypertension, Resistant to Conventional Therapy
Device: Covidien OneShot System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System

Resource links provided by NLM:


Further study details as provided by Maya Medical:

Primary Outcome Measures:
  • Acute Procedural Safety [ Time Frame: One Week ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Chronic Procedural Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months

  • RDN Procedure Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline


Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapid Renal Denervation Device: Covidien OneShot System
Placed percutaneously, the OneShotTM 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 Name: Covidien OneShot Renal Denervation System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. eGFR < 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520506

Contacts
Contact: Monica Tocchi, MD,PhD 00393931155344 medical@meditrialeurope.com

Locations
Belgium
Middelheim Hospital Recruiting
Antwerp, Belgium
Contact: Nancy Aerts       nancy.aerts@zna.be   
Principal Investigator: Stefan Verheye, MD         
Ziekenhuis Oost--Limburg Recruiting
Genk, Belgium, 3600
Contact: Joseph Dens, MD       Jo.Dens@zol.be   
Principal Investigator: Joseph Dens, MD         
Germany
Universitatklinikum Recruiting
Bonn, Germany
Contact: Nikos Werner       nwerner@uni-bonn.de   
Principal Investigator: Eberhard Grube, MD         
Cardiovascular Center Sankt Katharinen Recruiting
Frankfurt, Germany
Contact: R Eckhardt       r.eckhardt@cvcfrankfurt.de   
Principal Investigator: Horst Sievert, MD         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany
Contact: Karl Heinz Kuck, MD       KuckKH@aol.com   
Principal Investigator: Karl Heinz Kuck, MD         
Univ. Medical Klinik III Recruiting
Heidelberg, Germany
Contact: Erwin Blessing, MD         
Principal Investigator: Erwin Blessing, MD         
Franziskus Hospital Recruiting
Münster, Germany
Contact: Giovanni Torsello, MD         
Principal Investigator: Giovanni Torsello         
Italy
Hospital San Raffaele Recruiting
Milano, Italy
Contact: Antonio Colombo, MD         
Principal Investigator: Antonio Colombo, MD         
Luxembourg
Centre Hospitalier De Luxembourg Recruiting
Luxembourg, Luxembourg, L-1210
Contact: Daniel Wagner       wagner.daniel@chl.lu   
Principal Investigator: Daniel Wagner, MD         
Netherlands
Santa Catharina Hospital Recruiting
Eindhoven, Netherlands
Contact: Antoinette van der Pol       antoinette.vd.pol@catharinaziekenhuis.nl   
Principal Investigator: W.A.L. Tonino         
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: Benno Rensing, MD       b.rensing@antoniusziekenhuis.nl   
Principal Investigator: Benno Rensing, MD         
Erasmus MC Thoraxcenter Not yet recruiting
Rotterdam, Netherlands
Contact: Joost Daemen       j.daemen@erasmusmc.nl   
Principal Investigator: Joost Daemen, MD         
UMC Universitair Medisch Centrum Recruiting
Utrecht, Netherlands
Contact: Michiel Voskuil, MD       m.voskuil@umcutrecht.nl   
Principal Investigator: Michiel Voskuil, MD         
New Zealand
Mercy Angiography Unit Recruiting
Auckland, New Zealand
Contact: Rhona MacDonald       rhona@mercyangiography.co.nz   
Principal Investigator: John Ormiston         
Sponsors and Collaborators
Maya Medical
Covidien
Meditrial SrL
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
  More Information

Additional Information:
No publications provided

Responsible Party: Maya Medical
ClinicalTrials.gov Identifier: NCT01520506     History of Changes
Other Study ID Numbers: CIP 012
Study First Received: January 25, 2012
Last Updated: January 12, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maya Medical:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

Additional relevant MeSH terms:
Coronary Vasospasm
Hypertension
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014