I07.8
Conditions
Interventions
Group 1: Adult subjects with clinically significant, symptomatic, mitral and tricuspid regurgitation who are at high surgical risk for standard surgical repair or replacement as assessed by the Heart
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Signed and dated EC approved study consent form prior to study related procedures • Eighteen years of age or older • Clinically significant, symptomatic (NYHA Functional Class II or greater), combined mitral and tricuspid regurgitation (per applicable guidelines) requiring interventional valve repair of both (mitral and tricuspid) valves as assessed by the Heart Team. Based on surgical recommendations, the interventional combined mitral and tricuspid repair should be considered in patients: o With at least moderate-to-severe mitral regurgitation AND o with severe secondary TR OR o with at least moderate secondary TR with dilated annulus (=40 mm or >21 mm/m²) • NYHA Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy • Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for surgical valve repair or replacement and the benefit-risk analysis supports utilization of the MitraClip system • Willing to attend study follow-up assessments for up to 1 year
Exclusion criteria
Exclusion criteria: • Moderate or greater mitral or tricuspid valve stenosis o valve area < 3 cm2 o Inflow gradient = 5 mmHg • A right ventricular lead positioned through the tricuspid valve, which impeds valvular function • Carzinoid heart disease with valvular involvement • Untreated clinically significant coronary artery disease requiring immediate revascularization • Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure • Myocardial infarction within 30 days of scheduled implant procedure • Hemodynamic instability within 30 days of scheduled implant procedure • Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure • Patients with pulmonary artery systolic pressure 2/3 of systemic pressure via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 45 days • Concomitant clinically significant valve (aortic or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement • Active endocarditis or infection within 3 months of scheduled implant procedure • Cerebrovascular accident within 3 months of scheduled implant procedure • Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation • Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure • Evidence of right sided intracardiac mass, thrombus, or vegetation • Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve • Allergy to cobalt, chromium, nitinol or titanium • Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated • Patient is a current intravenous drug user • Female of child-bearing potential is pregnant or lactating • Patient is currently participating or has participated in another investigational drug or device study within 30 days of study screening activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the study will assess overall mortality at 1 month compared to a literature derived Performance Goal of 18% based on high-risk surgical outcomes for surgical tricuspid repair/replacement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural Success (at 1 month): • Alive, with • Successful deployment and correct positioning of the MitraClip in the tricuspid valve, and • No additional surgical or interventional procedures related to the tricuspid valve intervention, and • MR and TR reduction compared to baseline without transvalvular inflow gradient > 5mmHg • None of the following device or procedure related SAEs: o Life threatening bleeding o Major vascular or cardiac structural complications requiring intervention o Pericardial effusion requiring drainage or surgery (includes tamponade) o Severe heart failure or hypotension requiring IV inotrope, ultrafiltration or mechanical circulatory support o Prolonged intubation > 48 hours Clinical Outcomes (at Discharge, 1 month, 6 months & 12 months) • All-cause mortality, cardiac mortality •Re-hospitalization rates for the underlying condition (heart failure) • Re-intervention rates for the underlying condition (mitral or tricuspid regurgitation) • Change in peripheral edema/ascites as assessed by subject weight loss (kilograms) from baseline, dosage of diuretic drugs and edema/ascites score • Change in NYHA Class from baseline • Change in 6 minute walk test distance (meters) from baseline • Change in Quality of Life e.g. as assessed by the MLHF (Minnesota Living With Heart Failure) questionnaires from baseline • Change in laboratory markers for renal (creatinine, eGFR) and hepatic (yGT, GOT, GPT, PCHE, Bilirubin) function | — |
Countries
Germany
Contacts
Public ContactJörg Hausleiter
Klinikum der Universität München
Outcome results
None listed