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

April 29, 2013
April 30, 2013
April 2013
October 2016   (final data collection date for primary outcome measure)
Change in office systolic blood pressure (SBP) from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01844037 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
OneShot Renal Denervation Registry
Renal Denervation Using the OneShot Ablation System

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Heart Failure
  • Diabetes Mellitus
  • Sleep Apnea
Device: OneShot Ablation System
Renal denervation
Renal denervation
Patients will be treated with the OneShot ablation system
Intervention: Device: OneShot Ablation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
October 2018
October 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Karen Krygier Karen.krygier@covidien.com
Italy
 
NCT01844037
CP1002
Not Provided
Covidien
Covidien
Not Provided
Not Provided
Covidien
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP