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OneShot Renal Denervation Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01844037
First received: April 29, 2013
Last updated: November 11, 2014
Last verified: November 2014
  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 and 12 months post procedure ] [ Designated as safety issue: No ]
  • Change in office SBP [ Time Frame: 6 and 12 months post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2015 (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

Locations
Italy
Hospital San Raffaele
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: November 11, 2014
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on November 20, 2014