Comparing transcatheter valve-in-valve implantation to redo surgery for mitral valve dysfunction

Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction

This study is testing whether a new heart procedure called transcatheter valve-in-valve implantation works better than traditional surgery for younger patients with severe problems from their artificial mitral valves.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: N/A to 70 Years
• Sex: All
• Sponsor: Instituto Dante Pazzanese de Cardiologia (Academic / other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT04402931 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of transcatheter valve-in-valve implantation (TsMViV) compared to redo surgical mitral valve replacement (rSMVR) for patients with severe bioprosthetic mitral valve dysfunction. Patients aged under 70 with symptoms of heart failure will be randomized to receive either intervention after a thorough assessment by a heart team. The study aims to evaluate the safety, efficacy, and long-term outcomes of both procedures over a follow-up period of up to 10 years. The trial will also explore the cost-effectiveness of these treatment strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are patients under 70 years old experiencing severe symptoms of heart failure due to mitral bioprosthetic dysfunction.

Not a fit: Patients with mild symptoms or those over 70 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with bioprosthetic mitral valve dysfunction, potentially leading to improved recovery times and outcomes.

How similar studies have performed: While transcatheter approaches have shown promise in other studies, the specific comparison of TsMViV to rSMVR is relatively novel and not extensively tested.

Eligibility criteria

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.

Where this trial is running

São Paulo

• Instituto Dante Pazzanese de Cardiologia — São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Dimytri Siqueira, MD, PhD — Instituto Dante Pazzanese de Cardiologia
• Study coordinator: Dimytri Siqueira, MD, PhD

Conditions Mitral Prosthetic Valve Stenosis and Regurgitation; Mitral Prosthetic valve dysfunction