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Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01520506
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : September 16, 2015
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
Medtronic - MITG
Meditrial Europe Ltd.
Information provided by (Responsible Party):
Medtronic Endovascular

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension, Resistant to Conventional Therapy Device: Covidien OneShot™ System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
Study Start Date : May 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Covidien OneShot™ Renal Denervation System


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520506


Locations
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Belgium
Middelheim Hospital
Antwerp, Belgium
Ziekenhuis Oost--Limburg
Genk, Belgium, 3600
Germany
Universitatklinikum
Bonn, Germany
Cardiovascular Center Sankt Katharinen
Frankfurt, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Univ. Medical Klinik III
Heidelberg, Germany
Franziskus Hospital
Münster, Germany
Italy
Hospital San Raffaele
Milano, Italy
Luxembourg
Centre Hospitalier De Luxembourg
Luxembourg, Luxembourg, L-1210
Netherlands
Santa Catharina Hospital
Eindhoven, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus MC Thoraxcenter
Rotterdam, Netherlands
UMC Universitair Medisch Centrum
Utrecht, Netherlands
New Zealand
Mercy Angiography Unit
Auckland, New Zealand
Sponsors and Collaborators
Medtronic Endovascular
Medtronic - MITG
Meditrial Europe Ltd.
Investigators
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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
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01520506    
Other Study ID Numbers: CIP 012
First Posted: January 30, 2012    Key Record Dates
Results First Posted: September 16, 2015
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Medtronic Endovascular:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
 Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases