OneShot Renal Denervation Registry

This study has been terminated.
Information provided by (Responsible Party):
Medtronic Endovascular Identifier:
First received: April 29, 2013
Last updated: August 31, 2015
Last verified: August 2015
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
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

Further study details as provided by Medtronic Endovascular:

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 ]

Enrollment: 51
Study Start Date: July 2014
Study Completion Date: March 2015
Primary Completion Date: March 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


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

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
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Please refer to this study by its identifier: NCT01844037

Hospital San Raffaele
Milano, Italy
Sponsors and Collaborators
Medtronic Endovascular
  More Information

No publications provided

Responsible Party: Medtronic Endovascular Identifier: NCT01844037     History of Changes
Other Study ID Numbers: CP1002
Study First Received: April 29, 2013
Last Updated: August 31, 2015
Health Authority: Italy: Ethics Committee processed this record on November 27, 2015