Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07623083
Acronym
MASTER-TAVI II
Enrollment
300
Registered
2026-06-03
Start date
2026-06-05
Completion date
2034-06-05
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Mitral Regurgitation, Transcatheter Aortic Valve Implantation (TAVI), Tricuspid Regurgitation

Keywords

Aortic stenosis, Transcatheter aortic valve implantation (TAVI), Multivalvular heart disease, Mitral regurgitation, Tricuspid regurgitation, Structural heart disease, Valve disease management algorithm

Brief summary

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.

Interventions

None listed

Sponsors

Josep Rodes-Cabau
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality or re-hospitalization for worsening heart failureMinimum of 1 yearComposite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure

Secondary

MeasureTime frameDescription
All-cause mortality or re-hospitalization for worsening heart failure1 YearComposite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
All-cause mortality1 yearAll-cause mortality at 1 year
Heart failure re-hospitalization1 yearHeart failure re-hospitalization at 1 year
Cardiovascular mortality1 yearCardiovascular mortality at 1 year
All-cause mortality or heart failure re-hospitalization1 yearEvaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.
MR severity1 yearMR severity at 1 year
TR severity1 yearTR severity at 1 year
LVEF1 yearLVEF at 1 year

Contacts

CONTACTJosep Rodes Cabau, MD PhD
josep.rodes@criucpq.ulaval.ca14186568711
CONTACTMelanie Côté, MSc
melanie.cote@criucpq.ulaval.ca4186568711
PRINCIPAL_INVESTIGATORJosep Rodes Cabau, MD PhD

IUCPQ-UL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026