Status:
COMPLETED
Randomized Trial of Transcatheter Valve-in-Valve vs Redo Surgery for Bioprosthetic Mitral Dysfunction
Lead Sponsor:
Instituto Dante Pazzanese de Cardiologia
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Mitral Prosthetic Valve Stenosis and Regurgitation
Eligibility:
All Genders
Up to 70 years
Phase:
NA
Brief 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-v...
Detailed Description
Prospective, randomized, controlled trial of transeptal, transcatheter mitral valve-in-valve versus redo surgical mitral valve replacement. After multidisciplinary, heart team discussion, patients me...
Eligibility Criteria
Inclusion
- Age\>18 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
- 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.
Key Trial Info
Start Date :
February 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04402931
Start Date
February 17 2020
End Date
August 1 2025
Last Update
September 4 2025
Active Locations (7)
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1
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, Brazil, 60840285
2
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil, 41745900
3
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, Brazil, 22240006
4
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, Brazil, 88103901