Status:
TERMINATED
OneShot Renal Denervation Registry
Lead Sponsor:
Medtronic Endovascular
Conditions:
Hypertension
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01844037
Start Date
July 1 2014
End Date
March 1 2015
Last Update
September 2 2015
Active Locations (1)
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1
Hospital San Raffaele
Milan, Italy