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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01939392
First Posted: September 11, 2013
Last Update Posted: August 18, 2015
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.
Information provided by (Responsible Party):
Medtronic Endovascular
  Purpose
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 Intervention Phase
Resistant Hypertension Uncontrolled Hypertension Renal Artery Ablation Device: Renal Denervation (OneShot™ Renal Denervation System) Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: September 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
Italy
Hospital San Raffaele
Milano, Italy
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Liepzig
Principal Investigator: Guiseppe Mancia, MD Universita Minano-Bicocca, Ospedale San Gerardo di Monza
  More Information

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01939392     History of Changes
Other Study ID Numbers: CP-1003
First Submitted: September 6, 2013
First Posted: September 11, 2013
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases