Treatment of TRIcuspid Regurgitation with the MitraClip Study

• Conditions: I07.8; Other tricuspid valve diseases

• Registration Number: DRKS00013632
• Lead Sponsor: Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-20
• Study Completion: 2018-10-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 7

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

• 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.