Transventricular Off-pump Mitral Valve Repair (TRANSOM)
20. července 2026 aktualizováno: 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.
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
175
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Lisa Fornaresio, PhD
- Telefonní číslo: 443.927.3984
- E-mail: lisa.fornaresio@jhmi.edu
Studijní záloha kontaktů
- Jméno: Rachael Quinn, PhD
- Telefonní číslo: 410.955.2800
- E-mail: rquinn17@jhmi.edu
Studijní místa
-
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Maryland
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Baltimore, Maryland, Spojené státy, 21287
- Nábor
- Johns Hopkins Hospital
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Kontakt:
- Lisa Fornaresio, PhD
- Telefonní číslo: 443-927-3984
- E-mail: lisa.fornaresio@jhmi.edu
-
Kontakt:
- Rachael Quinn, PhD
- Telefonní číslo: 410.955.2800
- E-mail: rquinn17@jhmi.edu
-
Vrchní vyšetřovatel:
- James S. Gammie, MD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Primary Safety Endpoint: Composite Freedom from Major Adverse Events
Časové okno: 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
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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.
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30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
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Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention
Časové okno: 1 year post-index procedure.
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Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
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1 year post-index procedure.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Technical Success
Časové okno: Exit from operating room and up to 30 days post-procedure.
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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.
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Exit from operating room and up to 30 days post-procedure.
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Procedural Success
Časové okno: Exit from operating room and up to 30 days post-procedure.
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Procedural success includes technical success with absence of major adverse events, no structural or functional failure, and reduction of mitral regurgitation to acceptable levels.
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Exit from operating room and up to 30 days post-procedure.
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Patient Success
Časové okno: 1 year post-index procedure.
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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.
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1 year post-index procedure.
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Blood Product Usage
Časové okno: Perioperative through hospital discharge (an average of 4 days following the index procedure).
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Blood product usage intraoperatively or post-operatively following the index procedure, measured as the number of blood product units transfused.
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Perioperative through hospital discharge (an average of 4 days following the index procedure).
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Procedure Time
Časové okno: During the index procedure.
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Time from first incision to incision closure (hours).
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During the index procedure.
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Operating Room Time
Časové okno: During the index procedure.
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Time from entry into the operating room suite until exit from the operating room suite (hours).
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During the index procedure.
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Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
Časové okno: During the index procedure.
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Percentage of subjects receiving mitral valve replacement during the index procedure.
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During the index procedure.
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Composite Effectiveness Endpoint
Časové okno: 1 year post-index procedure.
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Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation.
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1 year post-index procedure.
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Discharged to Home vs Other Facility
Časové okno: At hospital discharge (an average of 4 days following the index procedure).
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Discharge disposition following hospitalization, including discharge to home versus another facility.
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At hospital discharge (an average of 4 days following the index procedure).
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New York Heart Association (NYHA) Functional Class
Časové okno: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
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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.
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Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
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Mitral Regurgitation Grade
Časové okno: 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.
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Measured by transthoracic echocardiogram.
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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.
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Left Ventricular End Diastolic Diameter (LVEDD)
Časové okno: 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.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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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.
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Left Ventricular End Systolic Diameter (LVESD)
Časové okno: 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.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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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.
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Left Ventricular End Diastolic Volume (LVEDV)
Časové okno: 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.
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Measured by transthoracic echocardiogram (mL).
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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.
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Left Ventricular End Systolic Volume (LVESV)
Časové okno: 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.
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Measured by transthoracic echocardiogram (mL).
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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.
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Left Ventricular Ejection Fraction (LVEF)
Časové okno: 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.
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Measured by transthoracic echocardiogram (%).
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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.
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Left Atrial Volume
Časové okno: 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.
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Measured by transthoracic echocardiogram (mL).
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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.
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Mitral Annular Septal-Lateral Dimension
Časové okno: 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.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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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.
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Right Ventricular Systolic Pressure (RVSP)
Časové okno: 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.
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Measured by transthoracic echocardiogram (mmHg).
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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.
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Mitral Valve Peak Gradient
Časové okno: 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.
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Measured by transthoracic echocardiogram (mmHg).
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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.
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Mitral Valve Mean Gradient
Časové okno: 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.
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Measured by transthoracic echocardiogram (mmHg).
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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.
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Tricuspid Valve Regurgitation (TVR) Grade
Časové okno: 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.
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Measured by transthoracic echocardiogram.
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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.
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Right Ventricular Function
Časové okno: 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.
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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).
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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.
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Ventilation Duration
Časové okno: At extubation (an average of 2 hours following the index procedure).
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Total ventilation duration following the index procedure (hours).
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At extubation (an average of 2 hours following the index procedure).
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Intensive Care Unit Length of Stay
Časové okno: At ICU discharge (an average of 1 day following the index procedure).
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Total intensive care unit length of stay following the index procedure (hours).
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At ICU discharge (an average of 1 day following the index procedure).
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Hospital Length of Stay
Časové okno: At hospital discharge (an average of 4 days following the index procedure).
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Total hospital length of stay following the index procedure (days).
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At hospital discharge (an average of 4 days following the index procedure).
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: James Gammie, MD, Johns Hopkins University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
8. června 2026
Primární dokončení (Odhadovaný)
1. července 2027
Dokončení studie (Odhadovaný)
1. července 2029
Termíny zápisu do studia
První předloženo
6. července 2026
První předloženo, které splnilo kritéria kontroly kvality
20. července 2026
První zveřejněno (Aktuální)
24. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
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