Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)
18 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
60
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Aakriti Gupta, M.D.
- Numer telefonu: 267-442-8776
- E-mail: aakriti.gupta@cshs.org
Lokalizacje studiów
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California
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Los Angeles, California, Stany Zjednoczone, 90048
- Rekrutacyjny
- Smidt Heart Institute, Cedars Sinai Medical Center
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Kontakt:
- Aakriti Gupta, M.D.
- Numer telefonu: 267-442-8776
- E-mail: aakriti.gupta@cshs.org
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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).
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
19 lutego 2025
Zakończenie podstawowe (Szacowany)
1 sierpnia 2027
Ukończenie studiów (Szacowany)
1 sierpnia 2027
Daty rejestracji na studia
Pierwszy przesłany
16 marca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
18 maja 2026
Pierwszy wysłany (Rzeczywisty)
26 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- STUDY00003584
- 1R56HL175516-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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