Functional mitral regurgitation - Chronic Heart Failure
Conditions
Interventions
The Device group will recieve the optimal standard of care therapy and the
MitraClip placement.
The Control group will only receive the optimal standard of care therapy ( by
ESC guidelines for heart
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR), as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the echocardiograpphy corelab. - Age between 18 years and 90 years old - Assessed by the investigator to be on optimal standard of care therapy for heart failure, as described in Section 5.7 Baseline Treatment Optimization, 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 50, within 90 days preceding randomization. Therapy 50 means optimal medical and/or device therapy includes optimal stabilization of symptoms with the use of appropriate evidence based therapies including medicines, revascularization and cardiac resynchronization therapy with or without cardioverter defibrillator as indicated per ESC guidelines( see for more explanation "aanvullende opmerkingen"..) - 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 =55mm determined by TTE within 90 days prior to randomization and confirmed by the ECL
Exclusion criteria
Exclusion criteria: For all Excl criteria see page 36-38 of CIP 2.0 - Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR), as determined by TEE. - 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 - Any cardiovascular hospitalization within the last 2 weeks immediately prior to randomization. - Evidence of acute coronary syndrome, TIA 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 - Mitral valve surgery is considered a therapeutic option for the subject - Renal replacement therapy - 6MWT distance > 450 meters - Contraindication to transseptal catheterization - subjects in whom TEE is contraindicated - Active infections requiring current antibiotic therapy - Severe right ventricular failure or severe tricuspid regurgitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations.. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 • Mitral Regurgitation (MR) severity of mild or mild-to-moderate at 12 months • Change in Left Ventricular End Diastolic Volume (LVEDV) at 12 months over baseline • Change in Left Ventricular End Systolic Volume (LVESV) at 12 months over baseline • Change in 6 Minute Walk Test (6MWT) distance at 12 months over baseline • Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months over baseline • New York Heart Association (NYHA) Functional Class I/II at 12 months over baseline In addition also Health Economic Endpoints: • Device procedure cost including device and associated equipment, operative time, staff time and length of hospital stay (Intensive Care Unit (ICU) and non-ICU) • All-cause re-hospitalizations (time to each hospitalization and length of each hospitalization) at 12 months and 24 months • Concomitant cardiac treatments (medications and invasive/semi-invasive procedures) • Discharge location after each hospitalization (e.g., home, home with home health care, skilled nursing, long-term acute care) • Inpatient and outpatient physician visits (related to MR and heart failure excluding scheduled trial-related follow-up visits) • Management of device-related adverse events | — |
Countries
Netherlands
Outcome results
None listed