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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01939392
First received: September 6, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Major adverse event (MAE) rate through 30 days post randomization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute Procedural Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Chronic procedural safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Reduction in SBP by >10 mmHg at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits [ Time Frame: 6, 12, 24, and 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 253
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939392

Contacts
Contact: Karen Krygier, MBA karen.krygier@covidien.com

Locations
Italy
Hospital San Raffaele Not yet recruiting
Milano, Italy
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Liepzig
Principal Investigator: Guiseppe Mancia, MD Universita Minano-Bicocca, Ospedale San Gerardo di Monza
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01939392     History of Changes
Other Study ID Numbers: CP-1003
Study First Received: September 6, 2013
Last Updated: September 6, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Covidien:
Resistant hypertension
Uncontrolled hypertension
Renal artery ablation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014