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

Updated on 19 February 2024

See if I qualify

Summary

Show definitions

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 Identifier	NCT04402931
Sponsor	Instituto Dante Pazzanese de Cardiologia
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

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

Summary

Description

Details

How to participate?

Similar trials to consider

Not finding what you're looking for?

Study AnnotationsStudy Notes

Add a private note

Study Definition

Add a private note

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

Summary

Description

Details

How to participate?

Similar trials to consider

Not finding what you're looking for?

Sign up as a volunteer to stay informed

Study AnnotationsStudy Notes

Add a private note

Study Definition

Add a private note