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Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)

18. maj 2026 opdateret af: 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:

  1. Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.
  2. Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI
  3. 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Rekruttering
        • Smidt Heart Institute, Cedars Sinai Medical Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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).

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Tidsramme: From procedure to 3 years after procedure
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
From procedure to 3 years after procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Tidsramme: At 30 days, 6 months, and 1 year after procedure
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.
At 30 days, 6 months, and 1 year after procedure
Left Ventricular Ejection Fraction by Transthoracic Echocardiography
Tidsramme: At 30 days, 6 months, and 1 year after procedure
Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, and 1 year after procedure
Mean Mitral Valve Gradient by Transthoracic Echocardiography
Tidsramme: At 30 days, 6 months, and 1 year after procedure
Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, and 1 year after procedure
Kansas City Cardiomyopathy Questionnaire Overall Summary Score
Tidsramme: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Six-Minute Walk Test Distance
Tidsramme: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Functional capacity will be assessed using the 6-minute walk test distance, measured in meters.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Physical Component Summary Score
Tidsramme: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Mental Component Summary Score
Tidsramme: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status. Higher scores indicate better mental health status.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With All-Cause Mortality
Tidsramme: At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With Heart Failure Hospitalization
Tidsramme: At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, 1 year, and 5 years after procedure
Mitral Valve Reintervention
Tidsramme: At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, 1 year, and 5 years after procedure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Tidsramme: From start of procedure to 30 days after procedure
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.
From start of procedure to 30 days after procedure
Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction
Tidsramme: From baseline CMR to 6 months after procedure
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.
From baseline CMR to 6 months after procedure
Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence
Tidsramme: From baseline CMR to 6 months after procedure
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.
From baseline CMR to 6 months after procedure
Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index
Tidsramme: From baseline CMR to 6 months after procedure
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.
From baseline CMR to 6 months after procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cedars-Sinai Medical Center

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. februar 2025

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

16. marts 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY00003584
  • 1R56HL175516-01 (U.S. NIH-bevilling/kontrakt)

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