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Rapid Renal Sympathetic Denervation for Resistant Hypertension II (RAPID II)

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: NCT01939392
Recruitment Status : Withdrawn
First Posted : September 11, 2013
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
  • Major adverse event (MAE) rate through 30 days post randomization [ Time Frame: 30 days ]
  • Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
  • Acute Procedural Safety [ Time Frame: 30 days ]
  • Chronic procedural safety [ Time Frame: 6 months ]
  • Reduction in SBP by >10 mmHg at 6 months [ Time Frame: 6 months ]
  • Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits [ Time Frame: 6, 12, 24, and 36 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid Renal Sympathetic Denervation for Resistant Hypertension II
Official Title  ICMJE Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II
Brief Summary This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Resistant Hypertension
  • Uncontrolled Hypertension
  • Renal Artery Ablation
Intervention  ICMJE Device: Renal Denervation (OneShot™ Renal Denervation System)
Other Names:
  • OneShot Ablation system
  • Catheter-based renal denervation
Study Arms  ICMJE
  • Experimental: Renal Denervation
    Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication.
    Intervention: Device: Renal Denervation (OneShot™ Renal Denervation System)
  • No Intervention: Optimal Medical Therapy
    Subjects randomized to the control arm will be maintained on antihypertensive medications.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 11, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2013)
253
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
  • Stable drug regimen including three or more anti-hypertensive medications including a diuretic

Exclusion Criteria:

  • Renal anatomy unsuitable for treatment
  • Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
  • Patient has Type I diabetes
  • Has scheduled or planned surgery within the next 6 months
  • Individual is pregnant nursing or plans to be pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939392
Other Study ID Numbers  ICMJE CP-1003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Liepzig
Principal Investigator: Guiseppe Mancia, MD Universita Minano-Bicocca, Ospedale San Gerardo di Monza
PRS Account Medtronic Endovascular
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP