Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28 mei 2026 bijgewerkt door: Josep Rodes-Cabau
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Studietype
Observationeel
Inschrijving (Geschat)
300
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Melanie Côté, MSc
- Telefoonnummer: 2646 4186568711
- E-mail: melanie.cote@criucpq.ulaval.ca
Studie Contact Back-up
- Naam: Josep Rodes Cabau, MD PhD
- Telefoonnummer: 5593 14186568711
- E-mail: josep.rodes@criucpq.ulaval.ca
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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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).
|
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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).
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Concomitant MR and TR
Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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All-cause mortality or re-hospitalization for worsening heart failure
Tijdsspanne: Minimum of 1 year
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Tijdsspanne: 1 Year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
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1 Year
|
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All-cause mortality or re-hospitalization for worsening heart failure
Tijdsspanne: 2 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up
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2 year
|
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All-cause mortality or re-hospitalization for worsening heart failure
Tijdsspanne: 3 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.
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3 year
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All-cause mortality or re-hospitalization for worsening heart failure
Tijdsspanne: 4 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.
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4 year
|
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All-cause mortality or re-hospitalization for worsening heart failure
Tijdsspanne: 5 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.
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5 year
|
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All-cause mortality
Tijdsspanne: 1 year
|
All-cause mortality at 1 year
|
1 year
|
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All-cause mortality
Tijdsspanne: 2 year
|
All-cause mortality at 2 year
|
2 year
|
|
All-cause mortality
Tijdsspanne: 3 year
|
All-cause mortality at 3 year
|
3 year
|
|
All-cause mortality
Tijdsspanne: 4 year
|
All-cause mortality at 4 year
|
4 year
|
|
All-cause mortality
Tijdsspanne: 5 year
|
All-cause mortality at 5 year
|
5 year
|
|
Heart failure re-hospitalization
Tijdsspanne: 1 year
|
Heart failure re-hospitalization at 1 year
|
1 year
|
|
Heart failure re-hospitalization
Tijdsspanne: 2 year
|
Heart failure re-hospitalization at 2 year
|
2 year
|
|
Heart failure re-hospitalization
Tijdsspanne: 3 year
|
Heart failure re-hospitalization at 3 year
|
3 year
|
|
Heart failure re-hospitalization
Tijdsspanne: 4 year
|
Heart failure re-hospitalization at 4 year
|
4 year
|
|
Heart failure re-hospitalization
Tijdsspanne: 5 year
|
Heart failure re-hospitalization at 5 year
|
5 year
|
|
Cardiovascular mortality
Tijdsspanne: 1 year
|
Cardiovascular mortality at 1 year
|
1 year
|
|
Cardiovascular mortality
Tijdsspanne: 2 year
|
Cardiovascular mortality at 2 year
|
2 year
|
|
Cardiovascular mortality
Tijdsspanne: 3 year
|
Cardiovascular mortality at 3 year
|
3 year
|
|
Cardiovascular mortality
Tijdsspanne: 4 year
|
Cardiovascular mortality at 4 year
|
4 year
|
|
Cardiovascular mortality
Tijdsspanne: 5 year
|
Cardiovascular mortality at 5 year
|
5 year
|
|
All-cause mortality or heart failure re-hospitalization
Tijdsspanne: 1 year
|
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
Tijdsspanne: 1 year
|
MR severity at 1 year
|
1 year
|
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MR severity
Tijdsspanne: 2 year
|
MR severity at 2 year
|
2 year
|
|
MR severity
Tijdsspanne: 3 year
|
MR severity at 3 year
|
3 year
|
|
MR severity
Tijdsspanne: 4 year
|
MR severity at 4 year
|
4 year
|
|
MR severity
Tijdsspanne: 5 year
|
MR severity at 5 year
|
5 year
|
|
TR severity
Tijdsspanne: 1 year
|
TR severity at 1 year
|
1 year
|
|
TR severity
Tijdsspanne: 2 year
|
TR severity at 2 year
|
2 year
|
|
TR severity
Tijdsspanne: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Tijdsspanne: 4 year
|
TR severity at 4 year
|
4 year
|
|
TR severity
Tijdsspanne: 5 year
|
TR severity at 5 year
|
5 year
|
|
LVEF
Tijdsspanne: 1 year
|
LVEF at 1 year
|
1 year
|
|
LVEF
Tijdsspanne: 2 year
|
LVEF at 2 year
|
2 year
|
|
LVEF
Tijdsspanne: 3 year
|
LVEF at 3 year
|
3 year
|
|
LVEF
Tijdsspanne: 4 year
|
LVEF at 4 year
|
4 year
|
|
LVEF
Tijdsspanne: 5 year
|
LVEF at 5 year
|
5 year
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
5 juni 2026
Primaire voltooiing (Geschat)
5 juni 2029
Studie voltooiing (Geschat)
5 juni 2034
Studieregistratiedata
Eerst ingediend
28 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 mei 2026
Eerst geplaatst (Werkelijk)
3 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
28 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MASTER-TAVI II
Plan Individuele Deelnemersgegevens (IPD)
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NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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