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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

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).

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: MitraClip® Procedure: Mitral valve Surgery Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy
Study Start Date : April 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
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.
Device: MitraClip®
one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory

Active Comparator: Surgery
Surgical therapy of degenerative mitral regurgitation: repair or replacement of mitral valve, clinical standard
Procedure: Mitral valve Surgery
Repair or replace mitral valve




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534155


Locations
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Germany
Universitätsklinikum Bonn
Bonn, Germany, 53127
Asklepios Klinik Hamburg St. Georg
Hamburg, Germany, 20099
Universitäres Herzzentrum Hamburg GmbH
Hamburg, Germany, 20246
Universitätsklinikum Köln, Herzzentrum
Köln, Germany, 50937
Klinikum der Universität München Großhadern
München, Germany, 81377
Helios Klinikum Siegburg
Siegburg, Germany, 53721
Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania, Italy, 95124
San Raffaele Hospital
Milano, Italy, 20132
Policlinico Tor Vergata
Roma, Italy, 00133
Switzerland
Inselspital Bern
Bern, Switzerland, 3010
Fondazione Cardiocentro Ticino
Lugano, Switzerland, 6900
Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Francesco Maisano, Prof. Universitätspital Zürich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02534155     History of Changes
Other Study ID Numbers: HiRiDe
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Keywords provided by University of Zurich:
MitraClip®
MR
DMR
high-risk patients
mitral regurgitation
surgery
intermediate risk patients
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases