OneShot Renal Denervation Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01844037
Recruitment Status : Terminated
First Posted : May 1, 2013
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Heart Failure Diabetes Mellitus Sleep Apnea Device: OneShot Ablation System Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation Using the OneShot Ablation System
Study Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Renal denervation
Patients will be treated with the OneShot ablation system
Device: OneShot Ablation System
Renal denervation

Primary Outcome Measures :
  1. Change in office systolic blood pressure (SBP) from baseline to 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention. [ Time Frame: One Week ]
  2. Change in office diastolic blood pressure (DBP) [ Time Frame: 6 and 12 months post procedure ]
  3. Change in office SBP [ Time Frame: 6 and 12 months post procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01844037

Hospital San Raffaele
Milano, Italy
Sponsors and Collaborators
Medtronic Endovascular

Responsible Party: Medtronic Endovascular Identifier: NCT01844037     History of Changes
Other Study ID Numbers: CP1002
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

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