Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Studietyp
Observationell
Inskrivning (Beräknad)
300
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Melanie Côté, MSc
- Telefonnummer: 2646 4186568711
- E-post: melanie.cote@criucpq.ulaval.ca
Studera Kontakt Backup
- Namn: Josep Rodes Cabau, MD PhD
- Telefonnummer: 5593 14186568711
- E-post: josep.rodes@criucpq.ulaval.ca
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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All-cause mortality or re-hospitalization for worsening heart failure
Tidsram: Minimum of 1 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure
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Minimum of 1 year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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All-cause mortality or re-hospitalization for worsening heart failure
Tidsram: 1 Year
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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
Tidsram: 2 year
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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
Tidsram: 3 year
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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
Tidsram: 4 year
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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
Tidsram: 5 year
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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
Tidsram: 1 year
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All-cause mortality at 1 year
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1 year
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All-cause mortality
Tidsram: 2 year
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All-cause mortality at 2 year
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2 year
|
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All-cause mortality
Tidsram: 3 year
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All-cause mortality at 3 year
|
3 year
|
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All-cause mortality
Tidsram: 4 year
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All-cause mortality at 4 year
|
4 year
|
|
All-cause mortality
Tidsram: 5 year
|
All-cause mortality at 5 year
|
5 year
|
|
Heart failure re-hospitalization
Tidsram: 1 year
|
Heart failure re-hospitalization at 1 year
|
1 year
|
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Heart failure re-hospitalization
Tidsram: 2 year
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Heart failure re-hospitalization at 2 year
|
2 year
|
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Heart failure re-hospitalization
Tidsram: 3 year
|
Heart failure re-hospitalization at 3 year
|
3 year
|
|
Heart failure re-hospitalization
Tidsram: 4 year
|
Heart failure re-hospitalization at 4 year
|
4 year
|
|
Heart failure re-hospitalization
Tidsram: 5 year
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Heart failure re-hospitalization at 5 year
|
5 year
|
|
Cardiovascular mortality
Tidsram: 1 year
|
Cardiovascular mortality at 1 year
|
1 year
|
|
Cardiovascular mortality
Tidsram: 2 year
|
Cardiovascular mortality at 2 year
|
2 year
|
|
Cardiovascular mortality
Tidsram: 3 year
|
Cardiovascular mortality at 3 year
|
3 year
|
|
Cardiovascular mortality
Tidsram: 4 year
|
Cardiovascular mortality at 4 year
|
4 year
|
|
Cardiovascular mortality
Tidsram: 5 year
|
Cardiovascular mortality at 5 year
|
5 year
|
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All-cause mortality or heart failure re-hospitalization
Tidsram: 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
Tidsram: 1 year
|
MR severity at 1 year
|
1 year
|
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MR severity
Tidsram: 2 year
|
MR severity at 2 year
|
2 year
|
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MR severity
Tidsram: 3 year
|
MR severity at 3 year
|
3 year
|
|
MR severity
Tidsram: 4 year
|
MR severity at 4 year
|
4 year
|
|
MR severity
Tidsram: 5 year
|
MR severity at 5 year
|
5 year
|
|
TR severity
Tidsram: 1 year
|
TR severity at 1 year
|
1 year
|
|
TR severity
Tidsram: 2 year
|
TR severity at 2 year
|
2 year
|
|
TR severity
Tidsram: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Tidsram: 4 year
|
TR severity at 4 year
|
4 year
|
|
TR severity
Tidsram: 5 year
|
TR severity at 5 year
|
5 year
|
|
LVEF
Tidsram: 1 year
|
LVEF at 1 year
|
1 year
|
|
LVEF
Tidsram: 2 year
|
LVEF at 2 year
|
2 year
|
|
LVEF
Tidsram: 3 year
|
LVEF at 3 year
|
3 year
|
|
LVEF
Tidsram: 4 year
|
LVEF at 4 year
|
4 year
|
|
LVEF
Tidsram: 5 year
|
LVEF at 5 year
|
5 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Studiestart (Beräknad)
5 juni 2026
Primärt slutförande (Beräknad)
5 juni 2029
Avslutad studie (Beräknad)
5 juni 2034
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28 maj 2026
Först inskickad som uppfyllde QC-kriterierna
28 maj 2026
Första postat (Faktisk)
3 juni 2026
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Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2026
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1 maj 2026
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