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

NCT ID: NCT04402931

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2025-08-01

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-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.

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 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.

Conditions

Mitral Prosthetic Valve Stenosis and Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transcatheter Valve-in-Valve Intervention

Transcatheter Valve-in-Valve Intervention

Group Type: OTHER

Transcatheter Valve-in-Valve Intervention

Intervention Type: PROCEDURE

Transcatheter mitral valve-in-valve implantation with SAPIEN 3

Redo Surgery

Surgical Mitral valve replacement

Group Type: OTHER

Redo Mitral valve surgery

Intervention Type: PROCEDURE

Transcatheter Valve-in-Valve Intervention

Interventions

Transcatheter Valve-in-Valve Intervention

Transcatheter mitral valve-in-valve implantation with SAPIEN 3

Intervention Type: PROCEDURE

Redo Mitral valve surgery

Transcatheter Valve-in-Valve Intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 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);
• 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.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: lead

Responsible Party

DIMYTRI ALEXANDRE DE ALVIM SIQUEIRA

Chief, Interventions in Acquired Valvular Heart Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimytri A Siqueira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Locations

Hospital de Messejana Dr. Carlos Alberto Studart Gomes

Fortaleza, Ceará, Brazil

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

UNIFESP

São Paulo, São Paulo, Brazil

Instituto do Coração (INCOR)

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

4993/2019

Identifier Type: -

Identifier Source: org_study_id