OneShot Renal Denervation Registry

Medtronic

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Hypertension; Diabetes Mellitus; Sleep Apnea; Heart Failure

Treatments: Device: OneShot Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844037

CP1002

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Renal denervation

Other group

Description:

Patients will be treated with the OneShot ablation system

Treatment:

Device: OneShot Ablation System