OneShot Renal Denervation Registry

Phase 2

Terminated

• Conditions: Sleep Apnea; Heart Failure; Diabetes Mellitus; Hypertension
• Interventions: Device: OneShot Ablation System

• Registration Number: NCT01844037
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-01
• Study Start: 2014-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation	OneShot Ablation System	Patients will be treated with the OneShot ablation system

Primary Outcome Measures

Name	Time	Method
Change in office systolic blood pressure (SBP) from baseline to 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.	One Week
Change in office diastolic blood pressure (DBP)	6 and 12 months post procedure
Change in office SBP	6 and 12 months post procedure

Trial Locations

Locations (1)

Hospital San Raffaele; 🇮🇹 Milano, Italy