Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Observationel
Tilmelding (Anslået)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Melanie Côté, MSc
- Telefonnummer: 2646 4186568711
- E-mail: melanie.cote@criucpq.ulaval.ca
Undersøgelse Kontakt Backup
- Navn: Josep Rodes Cabau, MD PhD
- Telefonnummer: 5593 14186568711
- E-mail: josep.rodes@criucpq.ulaval.ca
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Tidsramme: 1 Year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
|
1 Year
|
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All-cause mortality or re-hospitalization for worsening heart failure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
|
All-cause mortality at 1 year
|
1 year
|
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All-cause mortality
Tidsramme: 2 year
|
All-cause mortality at 2 year
|
2 year
|
|
All-cause mortality
Tidsramme: 3 year
|
All-cause mortality at 3 year
|
3 year
|
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All-cause mortality
Tidsramme: 4 year
|
All-cause mortality at 4 year
|
4 year
|
|
All-cause mortality
Tidsramme: 5 year
|
All-cause mortality at 5 year
|
5 year
|
|
Heart failure re-hospitalization
Tidsramme: 1 year
|
Heart failure re-hospitalization at 1 year
|
1 year
|
|
Heart failure re-hospitalization
Tidsramme: 2 year
|
Heart failure re-hospitalization at 2 year
|
2 year
|
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Heart failure re-hospitalization
Tidsramme: 3 year
|
Heart failure re-hospitalization at 3 year
|
3 year
|
|
Heart failure re-hospitalization
Tidsramme: 4 year
|
Heart failure re-hospitalization at 4 year
|
4 year
|
|
Heart failure re-hospitalization
Tidsramme: 5 year
|
Heart failure re-hospitalization at 5 year
|
5 year
|
|
Cardiovascular mortality
Tidsramme: 1 year
|
Cardiovascular mortality at 1 year
|
1 year
|
|
Cardiovascular mortality
Tidsramme: 2 year
|
Cardiovascular mortality at 2 year
|
2 year
|
|
Cardiovascular mortality
Tidsramme: 3 year
|
Cardiovascular mortality at 3 year
|
3 year
|
|
Cardiovascular mortality
Tidsramme: 4 year
|
Cardiovascular mortality at 4 year
|
4 year
|
|
Cardiovascular mortality
Tidsramme: 5 year
|
Cardiovascular mortality at 5 year
|
5 year
|
|
All-cause mortality or heart failure re-hospitalization
Tidsramme: 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
Tidsramme: 1 year
|
MR severity at 1 year
|
1 year
|
|
MR severity
Tidsramme: 2 year
|
MR severity at 2 year
|
2 year
|
|
MR severity
Tidsramme: 3 year
|
MR severity at 3 year
|
3 year
|
|
MR severity
Tidsramme: 4 year
|
MR severity at 4 year
|
4 year
|
|
MR severity
Tidsramme: 5 year
|
MR severity at 5 year
|
5 year
|
|
TR severity
Tidsramme: 1 year
|
TR severity at 1 year
|
1 year
|
|
TR severity
Tidsramme: 2 year
|
TR severity at 2 year
|
2 year
|
|
TR severity
Tidsramme: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Tidsramme: 4 year
|
TR severity at 4 year
|
4 year
|
|
TR severity
Tidsramme: 5 year
|
TR severity at 5 year
|
5 year
|
|
LVEF
Tidsramme: 1 year
|
LVEF at 1 year
|
1 year
|
|
LVEF
Tidsramme: 2 year
|
LVEF at 2 year
|
2 year
|
|
LVEF
Tidsramme: 3 year
|
LVEF at 3 year
|
3 year
|
|
LVEF
Tidsramme: 4 year
|
LVEF at 4 year
|
4 year
|
|
LVEF
Tidsramme: 5 year
|
LVEF at 5 year
|
5 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
5. juni 2026
Primær færdiggørelse (Anslået)
5. juni 2029
Studieafslutning (Anslået)
5. juni 2034
Datoer for studieregistrering
Først indsendt
28. maj 2026
Først indsendt, der opfyldte QC-kriterier
28. maj 2026
Først opslået (Faktiske)
3. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MASTER-TAVI II
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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