Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Resistant Hypertension Uncontrolled Hypertension Renal Artery Ablation Device: Renal Denervation (OneShot™ Renal Denervation System) Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Device: Renal Denervation (OneShot™ Renal Denervation System)
Other Names:
  • OneShot Ablation system
  • Catheter-based renal denervation
No Intervention: Optimal Medical Therapy
Subjects randomized to the control arm will be maintained on antihypertensive medications.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Major adverse event (MAE) rate through 30 days post randomization [ Time Frame: 30 days ]
  2. Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Acute Procedural Safety [ Time Frame: 30 days ]
  2. Chronic procedural safety [ Time Frame: 6 months ]
  3. Reduction in SBP by >10 mmHg at 6 months [ Time Frame: 6 months ]
  4. Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits [ Time Frame: 6, 12, 24, and 36 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01939392


Locations
Layout table for location information
Italy
Hospital San Raffaele
Milano, Italy
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Layout table for investigator information
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Liepzig
Principal Investigator: Guiseppe Mancia, MD Universita Minano-Bicocca, Ospedale San Gerardo di Monza
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01939392    
Other Study ID Numbers: CP-1003
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by Medtronic Endovascular:
Resistant hypertension
Uncontrolled hypertension
Renal artery ablation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases