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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
175
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.
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGPrimary Safety Endpoint: Composite Freedom from Major Adverse Events
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.
Time frame: 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
Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
Time frame: 1 year post-index procedure.
Technical Success
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.
Time frame: Exit from operating room and up to 30 days post-procedure.
Procedural Success
Procedural success includes technical success with absence of major adverse events, no structural or functional failure, and reduction of mitral regurgitation to acceptable levels.
Time frame: Exit from operating room and up to 30 days post-procedure.
Patient Success
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.
Time frame: 1 year post-index procedure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood Product Usage
Blood product usage intraoperatively or post-operatively following the index procedure, measured as the number of blood product units transfused.
Time frame: Perioperative through hospital discharge (an average of 4 days following the index procedure).
Procedure Time
Time from first incision to incision closure (hours).
Time frame: During the index procedure.
Operating Room Time
Time from entry into the operating room suite until exit from the operating room suite (hours).
Time frame: During the index procedure.
Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
Percentage of subjects receiving mitral valve replacement during the index procedure.
Time frame: During the index procedure.
Composite Effectiveness Endpoint
Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation.
Time frame: 1 year post-index procedure.
Discharged to Home vs Other Facility
Discharge disposition following hospitalization, including discharge to home versus another facility.
Time frame: At hospital discharge (an average of 4 days following the index procedure).
New York Heart Association (NYHA) Functional Class
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.
Time frame: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
Mitral Regurgitation Grade
Measured by transthoracic echocardiogram.
Time frame: 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)
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Time frame: 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)
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Time frame: 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)
Measured by transthoracic echocardiogram (mL).
Time frame: 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)
Measured by transthoracic echocardiogram (mL).
Time frame: 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)
Measured by transthoracic echocardiogram (%).
Time frame: 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
Measured by transthoracic echocardiogram (mL).
Time frame: 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
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Time frame: 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)
Measured by transthoracic echocardiogram (mmHg).
Time frame: 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
Measured by transthoracic echocardiogram (mmHg).
Time frame: 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
Measured by transthoracic echocardiogram (mmHg).
Time frame: 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
Measured by transthoracic echocardiogram.
Time frame: 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
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).
Time frame: 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
Total ventilation duration following the index procedure (hours).
Time frame: At extubation (an average of 2 hours following the index procedure).
Intensive Care Unit Length of Stay
Total intensive care unit length of stay following the index procedure (hours).
Time frame: At ICU discharge (an average of 1 day following the index procedure).
Hospital Length of Stay
Total hospital length of stay following the index procedure (days).
Time frame: At hospital discharge (an average of 4 days following the index procedure).