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MitraClip REPAIR MR Study

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ClinicalTrials.gov Identifier: NCT04198870
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE December 11, 2019
First Posted Date  ICMJE December 13, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE July 21, 2020
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
Survival free of stroke and any cardiovascular hospitalization at 2 years [ Time Frame: 2 Years ]
The proportion of subjects who are alive and without stroke or any CV hospitalization at 2 years in the Device and Control groups, respectively
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • Proportion of subjects with MR ≤ mild (1+) at 30 days post index procedure among survivors [ Time Frame: 30 Days ]
    The proportion of subjects with MR ≤ mild (1+) at 30 days post index procedure among survivors will be compared between the Device and Control groups
  • Rate of MV replacement at index procedure [ Time Frame: Index Procedure ]
    The proportion of subjects with MV replacement at index procedure in the Device group compared to the Control group
  • Number of days in hospital after index procedure [ 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
  • Proportion of patients 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
  • 5 point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) at 2 years [ Time Frame: 2 Years ]
    The proportion of subjects who have at least a 5 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MitraClip REPAIR MR Study
Official Title  ICMJE Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Regurgitation
Intervention  ICMJE
  • Device: MitraClip™ device implantation
    Transcatheter repair of the mitral valve using MitraClip™ device
  • Procedure: Mitral Valve Repair Surgery
    Surgical repair of the mitral valve
Study Arms  ICMJE
  • Control Arm
    Mitral Valve Repair Surgery
    Intervention: Procedure: Mitral Valve Repair Surgery
  • Experimental: Device Arm
    MitraClip™ device implantation
    Intervention: Device: MitraClip™ device implantation
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2032
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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: Janna Joyner 919-896-9476 janna.joyner@abbott.com
Listed Location Countries  ICMJE Canada,   Germany,   United States
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT04198870
Other Study ID Numbers  ICMJE ABT-CIP-10304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Abbott Medical Devices
Verification Date March 2021

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