Clinical trial NCT02534155: High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy
Official title: High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Mitral Valve Insufficiency
Keywords: MitraClip®
MR
DMR
high-risk patients
mitral regurgitation
surgery
intermediate risk patients
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 30-day safety superiority (ITT analysis): Major Adverse Event Composite
timeFrame: 30 days
measure: 12-month efficacy non-inferiority (ITT analysis): Proportion of responders in the Device vs. the Surgery group
timeFrame: 12 month
Secondary outcomes:
measure: Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month
timeFrame: 12 month
measure: MR Severity reduction at 6 and 12 month
timeFrame: between 6 and 12 month
measure: NYHA class changes at 6 and 12 months
timeFrame: between 6 and 12 month
measure: Change in 6MWT in 6 and 12 month
timeFrame: between 6 and 12 months
measure: Change in Quality of Life in 6 and 12 months
timeFrame: between 1 and 12 months
measure: Heart failure hospitalisation rate
timeFrame: during 12 months post procedure
measure: Days alive and out of hospital
timeFrame: during 12 months post procedure
measure: Hospital resources utilisations
timeFrame: during 12 months post procedure
measure: Change in Quality of Life (SF36) in 6 and 12 months
timeFrame: between 1 and 12 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH
city: Köln
country: Germany
facility: Universitätsklinikum Köln, Herzzentrum
city: München
country: Germany
facility: Klinikum der Universität München Großhadern
city: Siegburg
country: Germany
facility: Helios Klinikum Siegburg
city: Catania
country: Italy
facility: Presidio Ospedaliero Ferrarotto Alessi
city: Milano
country: Italy
facility: San Raffaele Hospital
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Lugano
country: Switzerland
facility: Fondazione Cardiocentro Ticino
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Universitätspital Zürich
name: Francesco Maisano, Prof.
role: PRINCIPAL_INVESTIGATOR
References: