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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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

Current Primary Outcome:

• 30-day safety superiority (ITT analysis): Major Adverse Event Composite [ Time Frame: 30 days ]
  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.
• 12-month efficacy non-inferiority (ITT analysis): Proportion of responders in the Device vs. the Surgery group [ Time Frame: 12 month ]
  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).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month [ Time Frame: 12 month ]
  Evaluation of all SAEs and SADEs that occur during the trial
• MR Severity reduction at 6 and 12 month [ Time Frame: between 6 and 12 month ]
  MR (Mitral Regurgitation) Severity reduction at 6 and 12 months in the MitraClip® and Surgery groups
• NYHA class changes at 6 and 12 months [ Time Frame: between 6 and 12 month ]
  NYHA class changes at 6 and 12 months in the MitraClip® and Surgery groups
• Change in 6MWT in 6 and 12 month [ Time Frame: between 6 and 12 months ]
  Change in 6MWT (6 Minute Walking Test) in 6 and 12 months in the MitraClip® and Surgery groups
• Change in Quality of Life in 6 and 12 months [ Time Frame: between 1 and 12 months ]
  Change in Quality of Life (MLWHF) at 1,6 and 12 month in the MitraClip® and Surgery groups
• Heart failure hospitalisation rate [ Time Frame: during 12 months post procedure ]
  Heart failure hospitalisation rate in the post randomisation in the MitraClip® and Surgery groups
• Days alive and out of hospital [ Time Frame: during 12 months post procedure ]
  Days alive and out of hospital in the 12 months post-randomisation in the MitraClip® and Surgery groups
• Hospital resources utilisations [ Time Frame: during 12 months post procedure ]
  Hospital resources utillizations: length of stay post-procedure, ICU beds occupancy, need for rehabilitation services
• Change in Quality of Life (SF36) in 6 and 12 months [ Time Frame: between 1 and 12 months ]
  Change in SF36 at 1,6 and 12 month in the MitraClip® and Surgery groups

Original Secondary Outcome:

• Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month [ Time Frame: 12 month ]
  Evaluation of all SAEs and SADEs that occur during the trial
• MR Severity reduction at 6 and 12 month [ Time Frame: between 6 and 12 month ]
  MR (Mitral Regurgitation) Severity reduction at 6 and 12 months in the MitraClip® and Surgery groups
• NYHA class changes at 6 and 12 months [ Time Frame: between 6 and 12 month ]
  NYHA class changes at 6 and 12 months in the MitraClip® and Surgery groups
• Change in 6MWT in 6 and 12 month [ Time Frame: between 6 and 12 months ]
  Change in 6MWT (6 Minute Walking Test) in 6 and 12 months in the MitraClip® and Surgery groups
• Change in Quality of Life in 6 and 12 months [ Time Frame: between 1 and 12 months ]
  Change in Quality of Life (MLWHF) at 1,6 and 12 month in the MitraClip® and Surgery groups
• Heart failure hospitalisation rate [ Time Frame: during 12 months post procedure ]
  Heart failure hospitalisation rate in the post randomisation in the MitraClip® and Surgery groups
• Days alive and out of hospital [ Time Frame: during 12 months post procedure ]
  Days alive and out of hospital in the 12 months post-randomisation in the MitraClip® and Surgery groups
• Hospital resources utilisations [ Time Frame: during 12 months post procedure ]
  Hospital resources utillizations: length of stay post-procedure, ICU beds occupancy, need for rehabilitation services

Dates:
Date Received: August 6, 2015
Date Started: April 2015
Date Completion: September 2018
Last Updated: September 8, 2016
Last Verified: September 2016