Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
300
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Melanie Côté, MSc
- Telefonnummer: 2646 4186568711
- E-Mail: melanie.cote@criucpq.ulaval.ca
Studieren Sie die Kontaktsicherung
- Name: Josep Rodes Cabau, MD PhD
- Telefonnummer: 5593 14186568711
- E-Mail: josep.rodes@criucpq.ulaval.ca
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 year
|
All-cause mortality at 1 year
|
1 year
|
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All-cause mortality
Zeitfenster: 2 year
|
All-cause mortality at 2 year
|
2 year
|
|
All-cause mortality
Zeitfenster: 3 year
|
All-cause mortality at 3 year
|
3 year
|
|
All-cause mortality
Zeitfenster: 4 year
|
All-cause mortality at 4 year
|
4 year
|
|
All-cause mortality
Zeitfenster: 5 year
|
All-cause mortality at 5 year
|
5 year
|
|
Heart failure re-hospitalization
Zeitfenster: 1 year
|
Heart failure re-hospitalization at 1 year
|
1 year
|
|
Heart failure re-hospitalization
Zeitfenster: 2 year
|
Heart failure re-hospitalization at 2 year
|
2 year
|
|
Heart failure re-hospitalization
Zeitfenster: 3 year
|
Heart failure re-hospitalization at 3 year
|
3 year
|
|
Heart failure re-hospitalization
Zeitfenster: 4 year
|
Heart failure re-hospitalization at 4 year
|
4 year
|
|
Heart failure re-hospitalization
Zeitfenster: 5 year
|
Heart failure re-hospitalization at 5 year
|
5 year
|
|
Cardiovascular mortality
Zeitfenster: 1 year
|
Cardiovascular mortality at 1 year
|
1 year
|
|
Cardiovascular mortality
Zeitfenster: 2 year
|
Cardiovascular mortality at 2 year
|
2 year
|
|
Cardiovascular mortality
Zeitfenster: 3 year
|
Cardiovascular mortality at 3 year
|
3 year
|
|
Cardiovascular mortality
Zeitfenster: 4 year
|
Cardiovascular mortality at 4 year
|
4 year
|
|
Cardiovascular mortality
Zeitfenster: 5 year
|
Cardiovascular mortality at 5 year
|
5 year
|
|
All-cause mortality or heart failure re-hospitalization
Zeitfenster: 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
Zeitfenster: 1 year
|
MR severity at 1 year
|
1 year
|
|
MR severity
Zeitfenster: 2 year
|
MR severity at 2 year
|
2 year
|
|
MR severity
Zeitfenster: 3 year
|
MR severity at 3 year
|
3 year
|
|
MR severity
Zeitfenster: 4 year
|
MR severity at 4 year
|
4 year
|
|
MR severity
Zeitfenster: 5 year
|
MR severity at 5 year
|
5 year
|
|
TR severity
Zeitfenster: 1 year
|
TR severity at 1 year
|
1 year
|
|
TR severity
Zeitfenster: 2 year
|
TR severity at 2 year
|
2 year
|
|
TR severity
Zeitfenster: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Zeitfenster: 4 year
|
TR severity at 4 year
|
4 year
|
|
TR severity
Zeitfenster: 5 year
|
TR severity at 5 year
|
5 year
|
|
LVEF
Zeitfenster: 1 year
|
LVEF at 1 year
|
1 year
|
|
LVEF
Zeitfenster: 2 year
|
LVEF at 2 year
|
2 year
|
|
LVEF
Zeitfenster: 3 year
|
LVEF at 3 year
|
3 year
|
|
LVEF
Zeitfenster: 4 year
|
LVEF at 4 year
|
4 year
|
|
LVEF
Zeitfenster: 5 year
|
LVEF at 5 year
|
5 year
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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Haupttermine studieren
Studienbeginn (Geschätzt)
5. Juni 2026
Primärer Abschluss (Geschätzt)
5. Juni 2029
Studienabschluss (Geschätzt)
5. Juni 2034
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Zuerst eingereicht
28. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Mai 2026
Zuerst gepostet (Tatsächlich)
3. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Mai 2026
Zuletzt verifiziert
1. Mai 2026
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- MASTER-TAVI II
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