OneShot Renal Denervation Registry

NCT ID: NCT01844037

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Hypertension Heart Failure Diabetes Mellitus Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal denervation

Patients will be treated with the OneShot ablation system

Group Type OTHER

OneShot Ablation System

Intervention Type DEVICE

Renal denervation

Interventions

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OneShot Ablation System

Renal denervation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Endovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital San Raffaele

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CP1002

Identifier Type: -

Identifier Source: org_study_id

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