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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory
Repair or replace mitral valve
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Köln, Herzzentrum
Cologne, Germany
Asklepios Klinik Hamburg St. Georg
Hamburg, Germany
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.
Time frame: 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).
Time frame: 12 month
Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month
Evaluation of all SAEs and SADEs that occur during the trial
Time frame: 12 month
MR Severity reduction at 6 and 12 month
MR (Mitral Regurgitation) Severity reduction at 6 and 12 months in the MitraClip® and Surgery groups
Time frame: between 6 and 12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 2 more locations
NYHA class changes at 6 and 12 months
NYHA class changes at 6 and 12 months in the MitraClip® and Surgery groups
Time frame: between 6 and 12 month
Change in 6MWT in 6 and 12 month
Change in 6MWT (6 Minute Walking Test) in 6 and 12 months in the MitraClip® and Surgery groups
Time frame: between 6 and 12 months
Change in Quality of Life in 6 and 12 months
Change in Quality of Life (MLWHF) at 1,6 and 12 month in the MitraClip® and Surgery groups
Time frame: between 1 and 12 months
Heart failure hospitalisation rate
Heart failure hospitalisation rate in the post randomisation in the MitraClip® and Surgery groups
Time frame: during 12 months post procedure
Days alive and out of hospital
Days alive and out of hospital in the 12 months post-randomisation in the MitraClip® and Surgery groups
Time frame: during 12 months post procedure
Hospital resources utilisations
Hospital resources utillizations: length of stay post-procedure, ICU beds occupancy, need for rehabilitation services
Time frame: during 12 months post procedure
Change in Quality of Life (SF36) in 6 and 12 months
Change in SF36 at 1,6 and 12 month in the MitraClip® and Surgery groups
Time frame: between 1 and 12 months