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

NCT02534155 | Terminated Phase 4 DMC

• 1 other identifier: HiRiDe
• Study Type: interventional
• Target: 294
• Locations: 3 countries
• Sites: 12

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).

Conditions

Mitral Valve Insufficiency

Keywords

MitraClip®; MR; DMR; high-risk patients; mitral regurgitation; surgery; intermediate risk patients

Outcome Measures

Primary Outcomes (2)

• 30-day safety superiority (ITT analysis): Major Adverse Event Composite

  The study is powered to show superiority for safety of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary safety endpoint is a Major Adverse Event Composite (MAE) including all-cause death, prolonged ventilation (\>48h), renal failure, stroke and need for non-elective cardiovascular or thoracic surgery (defined as any kind of cardiovascular and thoracic surgery performed within 30 days from the index procedure and non anticipated prior to the procedure). The analysis of the primary safety endpoint is a test of superiority for the proportion of subjects free from the composite of safety events in the Device vs. the Surgery group at 30 days.

  30 days

• 12-month efficacy non-inferiority (ITT analysis): Proportion of responders in the Device vs. the Surgery group

  The study is powered to show non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary effectiveness endpoint is a test of non-inferiority for the proportion of responders in the Device vs. the Surgery group at 12 months. Patients are defined as responders if they are alive with at least a 1-grade improvement in NYHA Functional Class at 12 months over baseline and have not experienced a HF hospitalization within 12 months of randomization (MitraClip® procedure or Surgery).

  12 month

Secondary Outcomes (9)

• Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month

  12 month

• MR Severity reduction at 6 and 12 month

  between 6 and 12 month

• NYHA class changes at 6 and 12 months

  between 6 and 12 month

• Change in 6MWT in 6 and 12 month

  between 6 and 12 months

• Change in Quality of Life in 6 and 12 months

  between 1 and 12 months

Study Arms (2)

MitraClip® Therapy

ACTIVE COMPARATOR

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.

Device: MitraClip®

Surgery

ACTIVE COMPARATOR

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

Procedure: Mitral valve Surgery

Interventions

MitraClip® DEVICE

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

MitraClip® Therapy

Mitral valve Surgery PROCEDURE

Repair or replace mitral valve

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (12)

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Köln, Herzzentrum

Cologne, 50937, Germany

Location

Asklepios Klinik Hamburg St. Georg

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, 20246, Germany

Location

Klinikum der Universität München Großhadern

München, 81377, Germany

Location

Helios Klinikum Siegburg

Siegburg, 53721, Germany

Location

Presidio Ospedaliero Ferrarotto Alessi

Catania, 95124, Italy

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Fondazione Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Francesco Maisano, Prof.

  Universitätspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 27, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

CH (3); DE (6); IT (3)