Mitral Valve (MV) Regurgitation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETRANSOM
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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Composite Freedom from Major Adverse Events | 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. |
| Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention | 1 year post-index procedure. | Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | 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. |
| Procedural Success | 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. |
| Patient Success | 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. |
| Blood Product Usage | 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. |
| Procedure Time | During the index procedure. | Time from first incision to incision closure (hours). |
| Operating Room Time | During the index procedure. | Time from entry into the operating room suite until exit from the operating room suite (hours). |
| Percentage of Subjects Receiving Mitral Valve Replacement (MVR) | During the index procedure. | Percentage of subjects receiving mitral valve replacement during the index procedure. |
| Composite Effectiveness Endpoint | 1 year post-index procedure. | Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation. |
| Discharged to Home vs Other Facility | At hospital discharge (an average of 4 days following the index procedure). | Discharge disposition following hospitalization, including discharge to home versus another facility. |
| New York Heart Association (NYHA) Functional Class | 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. |
| Mitral Regurgitation Grade | 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. |
| Left Ventricular End Diastolic Diameter (LVEDD) | 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). |
| Left Ventricular End Systolic Diameter (LVESD) | 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). |
| Left Ventricular End Diastolic Volume (LVEDV) | 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). |
| Left Ventricular End Systolic Volume (LVESV) | 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). |
| Left Ventricular Ejection Fraction (LVEF) | 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 (%). |
| Left Atrial Volume | 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). |
| Mitral Annular Septal-Lateral Dimension | 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). |
| Right Ventricular Systolic Pressure (RVSP) | 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). |
| Mitral Valve Peak Gradient | 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). |
| Mitral Valve Mean Gradient | 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). |
| Tricuspid Valve Regurgitation (TVR) Grade | 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. |
| Right Ventricular Function | 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). |
| Ventilation Duration | At extubation (an average of 2 hours following the index procedure). | Total ventilation duration following the index procedure (hours). |
| Intensive Care Unit Length of Stay | At ICU discharge (an average of 1 day following the index procedure). | Total intensive care unit length of stay following the index procedure (hours). |
| Hospital Length of Stay | At hospital discharge (an average of 4 days following the index procedure). | Total hospital length of stay following the index procedure (days). |
Countries
United States
Contacts
CONTACTLisa Fornaresio, PhD
CONTACTRachael Quinn, PhD
PRINCIPAL_INVESTIGATORJames Gammie, MD
Johns Hopkins University
Outcome results
None listed