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MitraClip REPAIR MR Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198870
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: MitraClip™ device implantation Procedure: Mitral Valve Repair Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2032

Arm Intervention/treatment
Control Arm
Mitral Valve Repair Surgery
Procedure: Mitral Valve Repair Surgery
Surgical repair of the mitral valve

Experimental: Device Arm
MitraClip™ device implantation
Device: MitraClip™ device implantation
Transcatheter repair of the mitral valve using MitraClip™ device




Primary Outcome Measures :
  1. All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded) [ Time Frame: 2 Years ]
    The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively

  2. Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) [ Time Frame: 2 Years ]
    Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively


Secondary Outcome Measures :
  1. Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors [ Time Frame: 30 Days ]
    The proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors will be compared between the Device and Control groups

  2. Number of days at hospital from index procedure to home discharge [ Time Frame: At Discharge (≤ 14 days following index procedure) ]
    Hospital length of stay from index procedure to home discharge (days) in Device group compared to the Control group

  3. Proportion of subjects discharged to home post index hospitalization [ Time Frame: At Discharge (≤ 14 days following index procedure) ]
    The proportion of subjects who are discharged to home post index hospitalization will be compared between the Device and Control groups

  4. Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors. [ Time Frame: 2 Years ]

    The proportion of subjects who have at least a 10 point improvement in KCCQ at 2 years post index procedure from baseline among survivors will be compared between the Device and Control groups for non-inferiority.

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered questionnaire used for quantifying patient's health status including the symptoms (frequency and burden), physical and social limitations, and quality of life impact due to the heart failure syndrome. Validity, reproducibility, responsiveness and interpretability of the scores have been independently established for each of these health status domains, and overall summary scores are reported in a range of 0-100, in which higher scores reflect better health status.


  5. Severe symptomatic mitral stenosis at 1 year [ Time Frame: 1 Year ]
    The proportion of subjects who have severe symptomatic mitral stenosis at 1 year post index procedure will be compared between the Device and Control groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL.
  • The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
  • Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery pressure systolic pressure > 50 mmHg, or LVESD > 40 mm.
  • Subject is at moderate surgical risk defined as being at least 75 years of age, OR if younger than 75 years, then has: (1) Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR (2) Presence of other comorbidities which may introduce a potential surgery-specific impediment.
  • Subject provides written informed consent.
  • Subject is ≥ 18 years of age.

Exclusion Criteria:

  • Subject is currently participating in another clinical investigation
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Subject has ischemic or non-ischemic secondary MR
  • Concomitant severe tricuspid valve regurgitation
  • Ejection fraction <30%
  • Severe mitral annular calcification
  • Acute myocardial infarction in the past 12 weeks
  • Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
  • Subjects who have concurrent coronary artery disease may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClipTM device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery
  • Surgical procedure performed in the past 30 days
  • Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
  • Transesophageal echocardiography (TEE) is contraindicated.
  • Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock or the need for inotropic support or IABP
  • Need for emergency surgery for any reason
  • Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
  • Systolic anterior motion of the mitral valve
  • Hypertrophic cardiomyopathy
  • Renal insufficiency requiring dialysis
  • Active infections requiring current antibiotic therapy
  • Subjects who are pregnant or planning to be pregnant

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): NCT04198870


Contacts
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Contact: Janna Joyner 919-896-9476 janna.joyner@abbott.com
Contact: Brian Crowe 651-756-2783 brian.crowe@abbott.com

Locations
Show Show 51 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Patrick McCarthy, MD Northwestern Memorial Hospital
Principal Investigator: Saibal Kar, MD Los Robles Regional Medical Center
Study Director: Kartik Sundareswaran, PhD Abbott Structural Heart
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04198870    
Other Study ID Numbers: ABT-CIP-10304
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
MitraClip
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases