Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)
18 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
60
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Aakriti Gupta, M.D.
- Telefoonnummer: 267-442-8776
- E-mail: aakriti.gupta@cshs.org
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90048
- Werving
- Smidt Heart Institute, Cedars Sinai Medical Center
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Contact:
- Aakriti Gupta, M.D.
- Telefoonnummer: 267-442-8776
- E-mail: aakriti.gupta@cshs.org
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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).
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
19 februari 2025
Primaire voltooiing (Geschat)
1 augustus 2027
Studie voltooiing (Geschat)
1 augustus 2027
Studieregistratiedata
Eerst ingediend
16 maart 2026
Eerst ingediend dat voldeed aan de QC-criteria
18 mei 2026
Eerst geplaatst (Werkelijk)
26 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
18 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- STUDY00003584
- 1R56HL175516-01 (Subsidie/contract van de Amerikaanse NIH)
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ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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