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

18. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

60

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90048
        • Rekrutierung
        • Smidt Heart Institute, Cedars Sinai Medical Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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).

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Cedars-Sinai Medical Center

Mitarbeiter

National Heart, Lung, and Blood Institute (NHLBI)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Februar 2025

Primärer Abschluss (Geschätzt)

1. August 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

16. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • STUDY00003584
  • 1R56HL175516-01 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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