A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

Abbott Medical Devices29 sites in 10 countries42 target enrollmentApril 2013

ConditionsCardiovascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: Abbott Medical Devices
Enrollment: 42
Locations: 29
Primary Endpoint: Hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.

Detailed Description

This study is a clinical evaluation of the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with chronic heart failure. The objective was to further study the safety and effectiveness of the MitraClip System for the treatment of clinically significant functional mitral regurgitation in New York Heart Association Functional Class III or IV chronic heart failure patients. Due to lower than expected recruitment rate, Abbott Vascular sponsorship of the trial was terminated early.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

January 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age between 18 years and 90 years old
•Clinically significant functional mitral regurgitation (moderate-to-severe or severe mitral regurgitation), as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory
•Assessed by the investigator to be on optimal standard of care therapy for heart failure for at least 4 weeks with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization
•Documented New York Heart Association Class III or Class IV heart failure, despite optimal standard of care therapy, within 90 days preceding randomization
•Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of at least 350 pg/mL for BNP or at least 1400 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization
•Left ventricular ejection fraction (LVEF) ≥15% and ≤40% determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory
•Left ventricular end diastolic diameter (LVEDD) ≥55 mm determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory
•Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness
•Subject agrees to return for all required post-procedure follow-up visits
•The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee

Exclusion Criteria

•Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative mitral regurgitation), as determined by transesophageal echocardiography
•Status 1 heart transplant or prior orthotopic heart transplantation
•Introduction of a new heart failure drug class within the last 4 weeks prior to randomization
•Cardiovascular hospitalization within the last 2 weeks immediately prior to randomization
•Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization
•Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to randomization
•Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD) within 90 days prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization
•Need for any cardiovascular surgery
•Mitral valve surgery is considered a therapeutic option for the subject
•Renal replacement therapy

Outcomes

Primary Outcomes

Hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations

Time Frame: two years

The analysis will be carried out when the last patient completes 12-month follow-up. All follow-up, up to 24 months, will be included in the analysis.

Secondary Outcomes

Change in 6 Minute Walk Test (6MWT) distance at 12 months over baseline(12 months)
Mitral regurgitation severity reduction to mild or mild-to-moderate at 12 months(12 months)
Composite of all-cause mortality, stroke, myocardial infarction, new need for renal replacement therapy, and non-elective cardiovascular surgery for device related complications in the Device group at 30 days(30 days)
Change in Left Ventricular End Diastolic Volume (LVEDV) at 12 months over baseline(12 months)
Change in Left Ventricular End Systolic Volume (LVESV) at 12 months over baseline(12 months)
Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), at 12 months over baseline(12 months)
New York Heart Association (NYHA) Functional Class I/II at 12 months(12 months)