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Transventricular Off-pump Mitral Valve Repair (TRANSOM)

20. juli 2026 oppdatert av: Johns Hopkins University

Transventricular Off-pump Mitral Valve Repair (TRANSOM)

The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The key advantages of TRANSOM are that it is less invasive, requiring a small non-rib-spreading chest incision rather than a sternotomy, which splits the breastbone.

Studietype

Intervensjonell

Registrering (Antatt)

175

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Rekruttering
        • Johns Hopkins Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • James S. Gammie, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age 21 years or older.
  • Presence of severe degenerative mitral regurgitation confirmed by echocardiography.
  • Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension.
  • Ability to provide informed consent and willingness to comply with study procedures and follow-up.

Exclusion Criteria:

  • Functional mitral regurgitation.
  • Severe mitral annular or leaflet calcification.
  • Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation).
  • Left ventricular ejection fraction <30% or severe right ventricular dysfunction.
  • Requirement for concomitant cardiac surgery.
  • Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).
  • Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).
  • Hemodynamic instability or cardiogenic shock at the time of enrollment.
  • Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.
  • Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.
  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Participation in another investigational device or drug study that could interfere with outcomes.
  • Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Transventricular off-pump mitral valve repair
Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation.
Enhet: TRANSOM
TRANSOM is a minimally-invasive treatment that involves making a small incision between the ribs of the left chest, inserting a thin tube directly into the heart while it is beating, and placing the suture material onto the edges of the valve flaps so that the valves come together properly.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Safety Endpoint: Composite Freedom from Major Adverse Events
Tidsramme: 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
Freedom from a composite of major adverse events including all-cause mortality, all stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker implantation, deep sternal wound infection (DSWI) or access site infection requiring surgical intervention, and prolonged mechanical ventilation.
30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention
Tidsramme: 1 year post-index procedure.
Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
1 year post-index procedure.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Technical Success
Tidsramme: Exit from operating room and up to 30 days post-procedure.
Technical success is defined as patient survival to exit from the operating room, successful implantation of at least three ePTFE cords, and absence of procedure-related emergency surgery or reintervention.
Exit from operating room and up to 30 days post-procedure.
Procedural Success
Tidsramme: Exit from operating room and up to 30 days post-procedure.
Procedural success includes technical success with absence of major adverse events, no structural or functional failure, and reduction of mitral regurgitation to acceptable levels.
Exit from operating room and up to 30 days post-procedure.
Patient Success
Tidsramme: 1 year post-index procedure.
Defined as procedural success with patient return to the pre-procedural living setting, absence of rehospitalization or reintervention for mitral regurgitation, and appropriate improvement or stability in New York Heart Association (NYHA) functional class.
1 year post-index procedure.
Blood Product Usage
Tidsramme: Perioperative through hospital discharge (an average of 4 days following the index procedure).
Blood product usage intraoperatively or post-operatively following the index procedure, measured as the number of blood product units transfused.
Perioperative through hospital discharge (an average of 4 days following the index procedure).
Procedure Time
Tidsramme: During the index procedure.
Time from first incision to incision closure (hours).
During the index procedure.
Operating Room Time
Tidsramme: During the index procedure.
Time from entry into the operating room suite until exit from the operating room suite (hours).
During the index procedure.
Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
Tidsramme: During the index procedure.
Percentage of subjects receiving mitral valve replacement during the index procedure.
During the index procedure.
Composite Effectiveness Endpoint
Tidsramme: 1 year post-index procedure.
Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation.
1 year post-index procedure.
Discharged to Home vs Other Facility
Tidsramme: At hospital discharge (an average of 4 days following the index procedure).
Discharge disposition following hospitalization, including discharge to home versus another facility.
At hospital discharge (an average of 4 days following the index procedure).
New York Heart Association (NYHA) Functional Class
Tidsramme: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
New York Heart Association functional class (Class I-IV), where Class I indicates no limitation of physical activity and Class IV indicates symptoms at rest; higher class indicates worse functional status.
Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
Mitral Regurgitation Grade
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram.
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Diastolic Diameter (LVEDD)
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Systolic Diameter (LVESD)
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Diastolic Volume (LVEDV)
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mL).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Systolic Volume (LVESV)
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mL).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular Ejection Fraction (LVEF)
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (%).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Atrial Volume
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mL).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Mitral Annular Septal-Lateral Dimension
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Right Ventricular Systolic Pressure (RVSP)
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mmHg).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Mitral Valve Peak Gradient
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mmHg).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Mitral Valve Mean Gradient
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mmHg).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Tricuspid Valve Regurgitation (TVR) Grade
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram.
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Right Ventricular Function
Tidsramme: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram using tricuspid annular plane systolic excursion (TAPSE) and global assessment of right ventricular function (normal, mild dysfunction, moderate dysfunction, or severe dysfunction).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Ventilation Duration
Tidsramme: At extubation (an average of 2 hours following the index procedure).
Total ventilation duration following the index procedure (hours).
At extubation (an average of 2 hours following the index procedure).
Intensive Care Unit Length of Stay
Tidsramme: At ICU discharge (an average of 1 day following the index procedure).
Total intensive care unit length of stay following the index procedure (hours).
At ICU discharge (an average of 1 day following the index procedure).
Hospital Length of Stay
Tidsramme: At hospital discharge (an average of 4 days following the index procedure).
Total hospital length of stay following the index procedure (days).
At hospital discharge (an average of 4 days following the index procedure).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Etterforskere

  • Hovedetterforsker: James Gammie, MD, Johns Hopkins University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. juni 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. juli 2029

Datoer for studieregistrering

Først innsendt

6. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00416988

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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