Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
300
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Melanie Côté, MSc
- Numero di telefono: 2646 4186568711
- Email: melanie.cote@criucpq.ulaval.ca
Backup dei contatti dello studio
- Nome: Josep Rodes Cabau, MD PhD
- Numero di telefono: 5593 14186568711
- Email: josep.rodes@criucpq.ulaval.ca
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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All-cause mortality or re-hospitalization for worsening heart failure
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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All-cause mortality or re-hospitalization for worsening heart failure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 3 year
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All-cause mortality at 3 year
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3 year
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All-cause mortality
Lasso di tempo: 4 year
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All-cause mortality at 4 year
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4 year
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All-cause mortality
Lasso di tempo: 5 year
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All-cause mortality at 5 year
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5 year
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Heart failure re-hospitalization
Lasso di tempo: 1 year
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Heart failure re-hospitalization at 1 year
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1 year
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Heart failure re-hospitalization
Lasso di tempo: 2 year
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Heart failure re-hospitalization at 2 year
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2 year
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Heart failure re-hospitalization
Lasso di tempo: 3 year
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Heart failure re-hospitalization at 3 year
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3 year
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Heart failure re-hospitalization
Lasso di tempo: 4 year
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Heart failure re-hospitalization at 4 year
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4 year
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Heart failure re-hospitalization
Lasso di tempo: 5 year
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Heart failure re-hospitalization at 5 year
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5 year
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Cardiovascular mortality
Lasso di tempo: 1 year
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Cardiovascular mortality at 1 year
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1 year
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Cardiovascular mortality
Lasso di tempo: 2 year
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Cardiovascular mortality at 2 year
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2 year
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Cardiovascular mortality
Lasso di tempo: 3 year
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Cardiovascular mortality at 3 year
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3 year
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Cardiovascular mortality
Lasso di tempo: 4 year
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Cardiovascular mortality at 4 year
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4 year
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Cardiovascular mortality
Lasso di tempo: 5 year
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Cardiovascular mortality at 5 year
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5 year
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All-cause mortality or heart failure re-hospitalization
Lasso di tempo: 1 year
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Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.
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1 year
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MR severity
Lasso di tempo: 1 year
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MR severity at 1 year
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1 year
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MR severity
Lasso di tempo: 2 year
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MR severity at 2 year
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2 year
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MR severity
Lasso di tempo: 3 year
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MR severity at 3 year
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3 year
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MR severity
Lasso di tempo: 4 year
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MR severity at 4 year
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4 year
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MR severity
Lasso di tempo: 5 year
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MR severity at 5 year
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5 year
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TR severity
Lasso di tempo: 1 year
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TR severity at 1 year
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1 year
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TR severity
Lasso di tempo: 2 year
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TR severity at 2 year
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2 year
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TR severity
Lasso di tempo: 3 year
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TR severity at 3 year
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3 year
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TR severity
Lasso di tempo: 4 year
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TR severity at 4 year
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4 year
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TR severity
Lasso di tempo: 5 year
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TR severity at 5 year
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5 year
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LVEF
Lasso di tempo: 1 year
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LVEF at 1 year
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1 year
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LVEF
Lasso di tempo: 2 year
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LVEF at 2 year
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2 year
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LVEF
Lasso di tempo: 3 year
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LVEF at 3 year
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3 year
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LVEF
Lasso di tempo: 4 year
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LVEF at 4 year
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4 year
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LVEF
Lasso di tempo: 5 year
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LVEF at 5 year
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5 year
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
5 giugno 2026
Completamento primario (Stimato)
5 giugno 2029
Completamento dello studio (Stimato)
5 giugno 2034
Date di iscrizione allo studio
Primo inviato
28 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 maggio 2026
Primo Inserito (Effettivo)
3 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MASTER-TAVI II
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .