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

NCT04402931 | Completed

• 1 other identifier: 4993/2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Mitral Prosthetic Valve Stenosis and Regurgitation

Keywords

Mitral Prosthetic valve dysfunction

Outcome Measures

Primary Outcomes (1)

• Rate of Major cardiovascular and Cerebrovascular events

  All-cause death; Cardiovascular death; Stroke

  12 months

Secondary Outcomes (5)

• Rate of Procedure-related complications

  30 days

• Rate of Rehospitalization

  12 months

• Rate of Prosthetic Thrombosis

  3 and 12 months

• Rate of Structural Valve dysfunction (as assessed by transthoracic echocardiography)

  10 years

• Rate of Bioprosthetic Valve Failure (as assessed by clinical outcomes and echocardiographic evaluations)

  10 years

Study Arms (2)

Transcatheter Valve-in-Valve Intervention

OTHER

Transcatheter Valve-in-Valve Intervention

Procedure: Transcatheter Valve-in-Valve Intervention

Redo Surgery

OTHER

Surgical Mitral valve replacement

Procedure: Redo Mitral valve surgery

Interventions

Transcatheter Valve-in-Valve Intervention PROCEDURE

Transcatheter mitral valve-in-valve implantation with SAPIEN 3

Transcatheter Valve-in-Valve Intervention

Redo Mitral valve surgery PROCEDURE

Transcatheter Valve-in-Valve Intervention

Redo Surgery

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead
• Edwards Lifesciences: collaborator

Study Sites (7)

Hospital de Messejana Dr. Carlos Alberto Studart Gomes

Fortaleza, Ceará, 60840285, Brazil

Location

Hospital Ana Nery

Salvador, Estado de Bahia, 41745900, Brazil

Location

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, 22240006, Brazil

Location

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, 88103901, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012909, Brazil

Location

UNIFESP

São Paulo, São Paulo, 04021001, Brazil

Location

Instituto do Coração (INCOR)

São Paulo, São Paulo, 05403900, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dimytri A Siqueira, MD, PhD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Interventions in Acquired Valvular Heart Disease

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 27, 2020
• Study Start: February 17, 2020
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (7)