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OneShot Renal Denervation Registry

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844037
First Posted: May 1, 2013
Last Update Posted: September 2, 2015
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.
Information provided by (Responsible Party):
Medtronic Endovascular
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01844037


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

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01844037     History of Changes
Other Study ID Numbers: CP1002
First Submitted: April 29, 2013
First Posted: May 1, 2013
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