Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Typ studie
Pozorovací
Zápis (Odhadovaný)
300
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Melanie Côté, MSc
- Telefonní číslo: 2646 4186568711
- E-mail: melanie.cote@criucpq.ulaval.ca
Studijní záloha kontaktů
- Jméno: Josep Rodes Cabau, MD PhD
- Telefonní číslo: 5593 14186568711
- E-mail: josep.rodes@criucpq.ulaval.ca
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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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).
|
|
Concomitant MR and TR
Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Časové okno: 1 Year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
|
1 Year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Časové okno: 2 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up
|
2 year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Časové okno: 3 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.
|
3 year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Časové okno: 4 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.
|
4 year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Časové okno: 5 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.
|
5 year
|
|
All-cause mortality
Časové okno: 1 year
|
All-cause mortality at 1 year
|
1 year
|
|
All-cause mortality
Časové okno: 2 year
|
All-cause mortality at 2 year
|
2 year
|
|
All-cause mortality
Časové okno: 3 year
|
All-cause mortality at 3 year
|
3 year
|
|
All-cause mortality
Časové okno: 4 year
|
All-cause mortality at 4 year
|
4 year
|
|
All-cause mortality
Časové okno: 5 year
|
All-cause mortality at 5 year
|
5 year
|
|
Heart failure re-hospitalization
Časové okno: 1 year
|
Heart failure re-hospitalization at 1 year
|
1 year
|
|
Heart failure re-hospitalization
Časové okno: 2 year
|
Heart failure re-hospitalization at 2 year
|
2 year
|
|
Heart failure re-hospitalization
Časové okno: 3 year
|
Heart failure re-hospitalization at 3 year
|
3 year
|
|
Heart failure re-hospitalization
Časové okno: 4 year
|
Heart failure re-hospitalization at 4 year
|
4 year
|
|
Heart failure re-hospitalization
Časové okno: 5 year
|
Heart failure re-hospitalization at 5 year
|
5 year
|
|
Cardiovascular mortality
Časové okno: 1 year
|
Cardiovascular mortality at 1 year
|
1 year
|
|
Cardiovascular mortality
Časové okno: 2 year
|
Cardiovascular mortality at 2 year
|
2 year
|
|
Cardiovascular mortality
Časové okno: 3 year
|
Cardiovascular mortality at 3 year
|
3 year
|
|
Cardiovascular mortality
Časové okno: 4 year
|
Cardiovascular mortality at 4 year
|
4 year
|
|
Cardiovascular mortality
Časové okno: 5 year
|
Cardiovascular mortality at 5 year
|
5 year
|
|
All-cause mortality or heart failure re-hospitalization
Časové okno: 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
Časové okno: 1 year
|
MR severity at 1 year
|
1 year
|
|
MR severity
Časové okno: 2 year
|
MR severity at 2 year
|
2 year
|
|
MR severity
Časové okno: 3 year
|
MR severity at 3 year
|
3 year
|
|
MR severity
Časové okno: 4 year
|
MR severity at 4 year
|
4 year
|
|
MR severity
Časové okno: 5 year
|
MR severity at 5 year
|
5 year
|
|
TR severity
Časové okno: 1 year
|
TR severity at 1 year
|
1 year
|
|
TR severity
Časové okno: 2 year
|
TR severity at 2 year
|
2 year
|
|
TR severity
Časové okno: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Časové okno: 4 year
|
TR severity at 4 year
|
4 year
|
|
TR severity
Časové okno: 5 year
|
TR severity at 5 year
|
5 year
|
|
LVEF
Časové okno: 1 year
|
LVEF at 1 year
|
1 year
|
|
LVEF
Časové okno: 2 year
|
LVEF at 2 year
|
2 year
|
|
LVEF
Časové okno: 3 year
|
LVEF at 3 year
|
3 year
|
|
LVEF
Časové okno: 4 year
|
LVEF at 4 year
|
4 year
|
|
LVEF
Časové okno: 5 year
|
LVEF at 5 year
|
5 year
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
5. června 2026
Primární dokončení (Odhadovaný)
5. června 2029
Dokončení studie (Odhadovaný)
5. června 2034
Termíny zápisu do studia
První předloženo
28. května 2026
První předloženo, které splnilo kritéria kontroly kvality
28. května 2026
První zveřejněno (Aktuální)
3. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MASTER-TAVI II
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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