Randomized Trial of Transcatheter Valve-in-Valve vs Redo Surgery for Bioprosthetic Mitral Dysfunction

  • STATUS
    Recruiting
  • End date
    Dec 5, 2031
  • participants needed
    150
  • sponsor
    Instituto Dante Pazzanese de Cardiologia
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Updated on 19 February 2024
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Summary

Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance. However, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. Studies of cost-effectiveness and cost-utility comparing both strategies were also not reported. In particular, late prosthesis durability and hemodynamic performance after TsMViV are largely unknown and need to be elucidated before widely indicated, especially among younger and low-risk surgical candidates with failed mitral bioprostheses.

Description

Prospective, randomized, controlled trial of transeptal, transcatheter mitral valve-in-valve versus redo surgical mitral valve replacement.

After multidisciplinary, heart team discussion, patients meeting inclusion criteria will be randomized 1:1 to receive either transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) with the SAPIEN 3 transcatheter heart valve (THV) or redo, mitral valve replacement with 3 commercially available surgical bioprosthetic valves. A sub-randomization in the surgical group will define which bioprosthetic valve will be used. Patients will be seen for follow-up visits at discharge, 30 days, 6 months and annually through 10 years.

Details
Condition Mitral Prosthetic Valve Stenosis and Regurgitation
Age 70years or below
Treatment Transcatheter Valve-in-Valve Intervention, Redo Mitral valve surgery
Clinical Study IdentifierNCT04402931
SponsorInstituto Dante Pazzanese de Cardiologia
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age<70 years
Symptoms of heart failure NYHA class>ll
Severe mitral bioprosthetic dysfunction (stenosis, regurgitation, mixed) defined by echocardiography
Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate
The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center
The study patient agreed to comply with all required post- procedure follow-up visits including annual visits through 10 years and analysis close date visits, which was conducted as a phone follow-up
Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present)
Patient agreed to undergo redo surgical mitral valve replacement (rSMVR) if randomized to control treatment

Exclusion Criteria

Heart Team assessment of inoperability (including examining cardiac surgeon)
Hostile chest
Evidence of an acute myocardial infarction < 1 month (30 days) before the intended treatment [defined as: Q wave Ml, or non-Q wave Ml with total creatine kinase (CK), creatine kinase MB isoform (CK-MB) and/or cardiac troponin elevations (WHO definition)]
Concomitant severe valvular disease (aortic, tricuspid or pulmonic) requiring surgical intervention
Mitral mechanical prosthesis or mitral valve rings
Preexisting mechanical or bioprosthetic valve in other position with dysfunction
Complex coronary artery disease: unprotected left main coronary artery, Syntax score > 32 (in the absence of prior revascularization)
Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not an exclusion criteria
Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation
Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb< 9 g/dL), thrombocytopenia (Pht< 50,000 cell/mL)
Hypertrophic cardiomyopathy with or without obstruction (HOCM)
Severe ventricular dysfunction with left-ventricular ejection fraction (LVEF) < 20%
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Active upper gastrointestinal (GI) bleeding within 3 months (90 days) prior to procedure
A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure
Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure
Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening
Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease
Currently participating in an investigational drug or another device study
Active bacterial endocarditis within 6 months (180 days) of procedure
Patient refuses redo mitral valve replacement surgery
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