Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis; Mitral Regurgitation; Tricuspid Regurgitation; Transcatheter Aortic Valve Implantation (TAVI)

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Melanie Côté, MSc; Phone Number: 2646 4186568711; Email: melanie.cote@criucpq.ulaval.ca
• Study Contact Backup: Name: Josep Rodes Cabau, MD PhD; Phone Number: 5593 14186568711; Email: josep.rodes@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• Age >18 years.
• Patients with severe AS undergoing transarterial TAVI.
• Concomitant significant MR and/or TR (≥3+).

Exclusion Criteria:

• 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.
• Subjects in whom transesophageal echocardiography is contraindicated or high risk.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Concomitant isolated MR - 3+ or 4; Patients with severe aortic stenosis (AS) and significant mitral regurgitation (MR) undergoing TAVI followed, if needed, by mitral intervention (M-TEER).
Concomitant isolated TR - 3+ to 5; Patients with severe AS and significant tricuspid regurgitation (TR) undergoing TAVI followed, if needed, by tricuspid intervention (T-TEER).
Concomitant MR and TR; Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Minimum of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Year
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	2 year
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.	3 year
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.	4 year
All-cause mortality or re-hospitalization for worsening heart failure	Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.	5 year
All-cause mortality	All-cause mortality at 1 year	1 year
All-cause mortality	All-cause mortality at 2 year	2 year
All-cause mortality	All-cause mortality at 3 year	3 year
All-cause mortality	All-cause mortality at 4 year	4 year
All-cause mortality	All-cause mortality at 5 year	5 year
Heart failure re-hospitalization	Heart failure re-hospitalization at 1 year	1 year
Heart failure re-hospitalization	Heart failure re-hospitalization at 2 year	2 year
Heart failure re-hospitalization	Heart failure re-hospitalization at 3 year	3 year
Heart failure re-hospitalization	Heart failure re-hospitalization at 4 year	4 year
Heart failure re-hospitalization	Heart failure re-hospitalization at 5 year	5 year
Cardiovascular mortality	Cardiovascular mortality at 1 year	1 year
Cardiovascular mortality	Cardiovascular mortality at 2 year	2 year
Cardiovascular mortality	Cardiovascular mortality at 3 year	3 year
Cardiovascular mortality	Cardiovascular mortality at 4 year	4 year
Cardiovascular mortality	Cardiovascular mortality at 5 year	5 year
All-cause mortality or heart failure re-hospitalization	Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.	1 year
MR severity	MR severity at 1 year	1 year
MR severity	MR severity at 2 year	2 year
MR severity	MR severity at 3 year	3 year
MR severity	MR severity at 4 year	4 year
MR severity	MR severity at 5 year	5 year
TR severity	TR severity at 1 year	1 year
TR severity	TR severity at 2 year	2 year
TR severity	TR severity at 3 year	3 year
TR severity	TR severity at 4 year	4 year
TR severity	TR severity at 5 year	5 year
LVEF	LVEF at 1 year	1 year
LVEF	LVEF at 2 year	2 year
LVEF	LVEF at 3 year	3 year
LVEF	LVEF at 4 year	4 year
LVEF	LVEF at 5 year	5 year

Collaborators and Investigators

• Sponsor: Josep Rodes-Cabau
• Investigators: Principal Investigator: Josep Rodes Cabau, MD PhD, IUCPQ-UL

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): June 5, 2029
• Study Completion (Estimated): June 5, 2034

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Structural heart disease; Aortic stenosis; Mitral regurgitation; Transcatheter aortic valve implantation (TAVI); Tricuspid regurgitation; Multivalvular heart disease; Valve disease management algorithm
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency
• Other Study ID Numbers: MASTER-TAVI II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared due to patient confidentiality and privacy considerations, as well as institutional and ethical restrictions governing the use of clinical research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No