Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)
18 maggio 2026 aggiornato da: Aakriti Gupta, Cedars-Sinai Medical Center
Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging
The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to:
- Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.
- Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI
- Assess patient-reported recovery and quality of life outcomes using validated tools.
The study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
This is an ambispective, (prospective and retrospective) cohort study collecting clinical, procedural, and follow-up data to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term.
Tipo di studio
Osservativo
Iscrizione (Stimato)
60
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: Aakriti Gupta, M.D.
- Numero di telefono: 267-442-8776
- Email: aakriti.gupta@cshs.org
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90048
- Reclutamento
- Smidt Heart Institute, Cedars Sinai Medical Center
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Contatto:
- Aakriti Gupta, M.D.
- Numero di telefono: 267-442-8776
- Email: aakriti.gupta@cshs.org
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-
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 includes adult patients with severe degenerative mitral regurgitation (DMR) who underwent either surgical mitral valve repair or transcatheter edge-to-edge repair (TEER).
Descrizione
Inclusion Criteria:
- Patients older than 60 years who have DMR will be included in the study
Exclusion Criteria:
- Patients with prior history of mitral intervention or surgery will be excluded.
- Patient records flagged "break the glass" or "research opt out" will be excluded.
- Persons with allergy to animal dander or animal-instigated asthma will be excluded.
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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Surgical mitral repair
This cohort includes patients who underwent surgical mitral valve repair for severe degenerative mitral regurgitation (DMR).
The intervention involves standard surgical techniques to repair the mitral valve, aiming to restore its physiological function and reduce mitral regurgitation.
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Transcatheter mitral edge-to-edge repair
This cohort includes patients who underwent transcatheter edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR).
The intervention involves a minimally invasive transcatheter procedure using a device to approximate the mitral valve leaflets, reducing regurgitation.
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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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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Lasso di tempo: From procedure to 3 years after procedure
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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
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From procedure to 3 years after procedure
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Lasso di tempo: At 30 days, 6 months, and 1 year after procedure
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Percentage of participants with residual mitral regurgitation greater than 2+ assessed by transthoracic echocardiography after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
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Left Ventricular Ejection Fraction by Transthoracic Echocardiography
Lasso di tempo: At 30 days, 6 months, and 1 year after procedure
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Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
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Mean Mitral Valve Gradient by Transthoracic Echocardiography
Lasso di tempo: At 30 days, 6 months, and 1 year after procedure
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Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
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Kansas City Cardiomyopathy Questionnaire Overall Summary Score
Lasso di tempo: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Kansas City Cardiomyopathy Questionnaire overall summary score, measured on a 0 to 100 scale, will be used to assess patient-reported health status after surgical mitral valve repair or transcatheter edge-to-edge repair.
Higher scores indicate better health status.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Six-Minute Walk Test Distance
Lasso di tempo: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Functional capacity will be assessed using the 6-minute walk test distance, measured in meters.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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SF-36 Physical Component Summary Score
Lasso di tempo: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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The SF-36 Physical Component Summary score will be used to assess patient-reported physical health status.
Scores are reported as scale scores, with higher scores indicating better physical health status.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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SF-36 Mental Component Summary Score
Lasso di tempo: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status.
Higher scores indicate better mental health status.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of Participants With All-Cause Mortality
Lasso di tempo: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of Participants With Heart Failure Hospitalization
Lasso di tempo: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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Mitral Valve Reintervention
Lasso di tempo: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Lasso di tempo: From start of procedure to 30 days after procedure
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Percentage of participants with one or more major periprocedural or 30-day complications after surgical mitral valve repair or transcatheter edge-to-edge repair.
Major complications include coronary obstruction, cardiac tamponade, new left bundle branch block, major bleeding, stroke or transient ischemic attack, myocardial infarction, acute kidney injury, new-onset atrial fibrillation, infection or sepsis, permanent pacemaker implantation, or conversion to open surgery.
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From start of procedure to 30 days after procedure
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Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction
Lasso di tempo: From baseline CMR to 6 months after procedure
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Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular ejection fraction, measured as percentage by transthoracic echocardiography at 6 months after procedure.
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From baseline CMR to 6 months after procedure
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Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence
Lasso di tempo: From baseline CMR to 6 months after procedure
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Difference in 6-month left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, between participants with and without baseline late gadolinium enhancement on cardiovascular magnetic resonance imaging.
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From baseline CMR to 6 months after procedure
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Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index
Lasso di tempo: From baseline CMR to 6 months after procedure
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Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular end-systolic volume index, measured in mL/m² by cardiovascular magnetic resonance imaging at 6 months after procedure.
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From baseline CMR to 6 months after procedure
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
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 (Effettivo)
19 febbraio 2025
Completamento primario (Stimato)
1 agosto 2027
Completamento dello studio (Stimato)
1 agosto 2027
Date di iscrizione allo studio
Primo inviato
16 marzo 2026
Primo inviato che soddisfa i criteri di controllo qualità
18 maggio 2026
Primo Inserito (Effettivo)
26 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- STUDY00003584
- 1R56HL175516-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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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
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