High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy

NCT ID: NCT02534155

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-09-30

Brief Summary

The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs. surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12 months post-procedure).

Detailed Description

Two-arm, multi-centre, randomised prospective study comparing MitraClip® to Surgical therapy in high and intermediate risk patients. Patients should be older than 18 years and high and intermediate risk is defined by a score (for MV repair) >= 3% and <= 10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors. Patients are selected upon clinical conditions and severity of MR. Anatomical feasibility is assessed by ECHO, according to the IFU (information for use).

The purpose of the trial is to evaluate safety and efficacy of MitraClip® vs. surgery in high and intermediate risk patients with DMR. Study Follow-Up includes the following visits after procedure: Hospital discharge, 1, 6, 12 months post-procedure.

Primary Endpoints are the 30-day safety superiority (ITT analysis) and the 12-month efficacy non-inferiority (ITT analysis) of the MitraClip®. The overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) until 12 months and the MR Severity reduction at 6 and 12 month in the MitraClip® and Surgery groups are Secondary Endpoints

Conditions

Mitral Valve Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MitraClip® Therapy

MitraClip® system is a CE marked medical device, which consists of two parts (Clip Delivery System and Steerable Guide Catheter). It is a single sized, percutaneously implanted mechanical Clip. The MitraClip® device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The procedure is performed in the cardiac catheterisation laboratory with echocardiographic and fluoroscopic guidance while the patient is under general anaesthesia.

Group Type: ACTIVE_COMPARATOR

MitraClip®

Intervention Type: DEVICE

one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory

Surgery

Surgical therapy of degenerative mitral regurgitation: repair or replacement of mitral valve, clinical standard

Group Type: ACTIVE_COMPARATOR

Mitral valve Surgery

Intervention Type: PROCEDURE

Repair or replace mitral valve

Interventions

MitraClip®

one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory

Intervention Type: DEVICE

Mitral valve Surgery

Repair or replace mitral valve

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Gender: Both, male and female
• Minimum Age: 18 Years
• Maximum Age: no maximum age
• Severe (4+) DMR (degenerative mitral regurgitation), or 3+ DMR
• NYHA Functional Class III or IV
• Mitral valve anatomy should be suitable for both MitraClip® and Mitral valve surgery (repair or replacement)
• Subjects meet the following conditions:

Age >18 and high or intermediate risk patients with an STS calculated mortality (using the repair calculator) >=3% and <=10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors

• patient is operable
• Signed by the subject and dated approved informed consent prior to any study related procedure
• Available and able to return to study site for post-procedural follow-up examination

Exclusion Criteria

• Patient incapable to approve the informed consent or Emergency Cases
• functional mitral valve pathology
• evolving endocarditis or active endocarditis in the last 3 months
• heavily calcified leaflets
• subjects in whom transesophageal echocardiography is contraindicated
• subjects in whom transseptal catheterisation is contraindicated
• presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year
• currently participating in the study of an investigational drug or device
• untreated clinically significant CAD requiring revascularisation
• any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
• prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
• concomitant and significant aortic or tricuspid valve pathology
• CVA or TIA within 6 months or severe carotid stenosis (>70% assessed by Ultrasound)
• contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately managed with premedication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Maisano, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätspital Zürich

Locations

Universitätsklinikum Bonn

Bonn, , Germany

Universitätsklinikum Köln, Herzzentrum

Cologne, , Germany

Asklepios Klinik Hamburg St. Georg

Hamburg, , Germany

Universitäres Herzzentrum Hamburg GmbH

Hamburg, , Germany

Klinikum der Universität München Großhadern

München, , Germany

Helios Klinikum Siegburg

Siegburg, , Germany

Presidio Ospedaliero Ferrarotto Alessi

Catania, , Italy

San Raffaele Hospital

Milan, , Italy

Policlinico Tor Vergata

Roma, , Italy

Universitätsspital Zürich

Zurich, Canton of Zurich, Switzerland

Inselspital Bern

Bern, , Switzerland

Fondazione Cardiocentro Ticino

Lugano, , Switzerland

Countries

Germany; Italy; Switzerland

Other Identifiers

HiRiDe

Identifier Type: -

Identifier Source: org_study_id