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

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ClinicalTrials.gov Identifier: NCT02534155
Recruitment Status : Terminated
First Posted : August 27, 2015
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE August 6, 2015
First Posted Date  ICMJE August 27, 2015
Last Update Posted Date September 9, 2016
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2015)
  • 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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02534155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2016)
  • 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 Measures  ICMJE
 (submitted: August 24, 2015)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy
Official Title  ICMJE 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 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Insufficiency
Intervention  ICMJE
  • Device: MitraClip®
    one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory
  • Procedure: Mitral valve Surgery
    Repair or replace mitral valve
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Device: MitraClip®
  • Active Comparator: Surgery
    Surgical therapy of degenerative mitral regurgitation: repair or replacement of mitral valve, clinical standard
    Intervention: Procedure: Mitral valve Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: August 24, 2015)
294
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02534155
Other Study ID Numbers  ICMJE HiRiDe
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesco Maisano, Prof. Universitätspital Zürich
PRS Account University of Zurich
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP