Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJosep Rodes-Cabau

About this trial

Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.

Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.

In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.

This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.

The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.

The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.

The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years.

Patients with severe AS undergoing transarterial TAVI.

Concomitant significant MR and/or TR (≥3+).

Disqualifiers

Life expectancy <1 year due to noncardiac conditions.

Any prior mitral or tricuspid valve surgery.

Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.

Active endocarditis.

Trial population

The study population will consist of adult patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) who also present with significant concomitant mitral regurgitation and/or tricuspid regurgitation. The study will mainly include elderly patients and patients considered at intermediate, high, or prohibitive surgical risk for conventional open-heart surgery. Eligible participants will have moderate-to-severe or severe mitral and/or tricuspid valve regurgitation identified by echocardiography before TAVI. Patients will be evaluated and treated according to a staged transcatheter treatment algorithm based on current clinical guidelines and the evolution of valve disease following TAVI.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: Concomitant isolated MR - 3+ or 4
Group B: Concomitant isolated TR - 3+ to 5
Group C: Concomitant MR and TR

Trial outcomes

Primary outcomes

1

All-cause mortality or re-hospitalization for worsening heart failure

Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure

Time frame
Minimum of 1 year

Secondary outcomes

1

All-cause mortality or re-hospitalization for worsening heart failure

Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.

Time frame
1 Year
2

All-cause mortality or re-hospitalization for worsening heart failure

Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up

Time frame
2 year
3

All-cause mortality or re-hospitalization for worsening heart failure

Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.

Time frame
3 year
4

All-cause mortality or re-hospitalization for worsening heart failure

Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.

Time frame
4 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Josep Rodes-Cabau

Lead sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Sponsor institution

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