OneShot Renal Denervation Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01844037
First received: April 29, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.


Condition Intervention Phase
Hypertension
Heart Failure
Diabetes Mellitus
Sleep Apnea
Device: OneShot Ablation System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation Using the OneShot Ablation System

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Change in office systolic blood pressure (SBP) from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention. [ Time Frame: One Week ] [ Designated as safety issue: Yes ]
  • Change in office diastolic blood pressure (DBP) [ Time Frame: 6, 12, 24, and 36 months post procedure ] [ Designated as safety issue: No ]
  • Change in office SBP [ Time Frame: 6, 12, 24, and 36 months post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Renal denervation
Patients will be treated with the OneShot ablation system
Device: OneShot Ablation System
Renal denervation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
  • Patient is ≥ 18 years old.
  • Patient provided written informed consent.

Exclusion Criteria:

  • Patients who are pregnant, nursing, or planning to become pregnant.
  • Patients who have only one functioning kidney.
  • Allergy to contrast or known hypersensitivity to device materials
  • Patients with renal arteries < 4 mm in diameter.
  • Patients whose life expectancy is less than the planned period of study involvement.
  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: NCT01844037

Contacts
Contact: Karen Krygier Karen.krygier@covidien.com

Locations
Italy
Hospital San Raffaele Recruiting
Milano, Italy
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01844037     History of Changes
Other Study ID Numbers: CP1002
Study First Received: April 29, 2013
Last Updated: April 30, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Hypertension
Diabetes Mellitus
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014