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

August 14, 2015 updated by: Medtronic Endovascular

Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Hospital San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse event (MAE) rate through 30 days post randomization
Time Frame: 30 days
30 days
Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute Procedural Safety
Time Frame: 30 days
30 days
Chronic procedural safety
Time Frame: 6 months
6 months
Reduction in SBP by >10 mmHg at 6 months
Time Frame: 6 months
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
6, 12, 24, and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Investigators

  • Principal Investigator: Dierk Scheinert, MD, Park-Krankenhaus Liepzig
  • Principal Investigator: Guiseppe Mancia, MD, Universita Minano-Bicocca, Ospedale San Gerardo di Monza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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