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Transventricular Off-pump Mitral Valve Repair (TRANSOM)

20 juli 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

175

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21287
        • Rekrytering
        • Johns Hopkins Hospital
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • James S. Gammie, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Primary Safety Endpoint: Composite Freedom from Major Adverse Events
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Technical Success
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: During the index procedure.
Time from first incision to incision closure (hours).
During the index procedure.
Operating Room Time
Tidsram: 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)
Tidsram: During the index procedure.
Percentage of subjects receiving mitral valve replacement during the index procedure.
During the index procedure.
Composite Effectiveness Endpoint
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).

Samarbetspartners och utredare

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Sponsor

Johns Hopkins University

Utredare

  • Huvudutredare: James Gammie, MD, Johns Hopkins University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 juni 2026

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

1 juli 2029

Studieregistreringsdatum

Först inskickad

6 juli 2026

Först inskickad som uppfyllde QC-kriterierna

20 juli 2026

Första postat (Faktisk)

24 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00416988

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