Back to resultsOneShot Renal Denervation Registry
Primary Purpose
Hypertension, Heart Failure, Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
OneShot Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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.
Sites / Locations
- Hospital San Raffaele
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Renal denervation
Arm Description
Patients will be treated with the OneShot ablation system
Outcomes
Primary Outcome Measures
Change in office systolic blood pressure (SBP) from baseline to 6 months
Secondary Outcome Measures
Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.
Change in office diastolic blood pressure (DBP)
Change in office SBP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01844037
Brief Title
OneShot Renal Denervation Registry
Official Title
Renal Denervation Using the OneShot Ablation System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Heart Failure, Diabetes Mellitus, Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal denervation
Arm Type
Other
Arm Description
Patients will be treated with the OneShot ablation system
Intervention Type
Device
Intervention Name(s)
OneShot Ablation System
Intervention Description
Renal denervation
Primary Outcome Measure Information:
Title
Change in office systolic blood pressure (SBP) from baseline to 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.
Time Frame
One Week
Title
Change in office diastolic blood pressure (DBP)
Time Frame
6 and 12 months post procedure
Title
Change in office SBP
Time Frame
6 and 12 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital San Raffaele
City
Milano
Country
Italy
12. IPD Sharing Statement
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OneShot Renal Denervation Registry
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