[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07726173":3,"trial-entities:NCT07726173":184,"trial-summary:NCT07726173":188},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":44,"sex":124,"minimum_age":125,"maximum_age":126,"healthy_volunteers":127,"eligibility_criteria":128,"std_ages":149,"locations":152,"central_contacts":175,"overall_officials":179,"references":182,"see_also_links":183},"NCT07726173","IRB00416988","Transventricular Off-pump Mitral Valve Repair","Transventricular Off-pump Mitral Valve Repair (TRANSOM)","RECRUITING","2029-07-01","2026-07","2026-07-24","2026-06-08","Johns Hopkins University","OTHER",true,"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.",[19],"Mitral Valve (MV) Regurgitation",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},175,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","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.",[34],"Transventricular off-pump mitral valve repair",[36,40],{"measure":37,"description":38,"timeFrame":39},"Primary 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.","30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure",{"measure":41,"description":42,"timeFrame":43},"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.","1 year post-index procedure.",[45,49,52,55,59,63,66,69,72,76,80,84,87,89,92,94,97,99,101,104,106,108,110,113,117,121],{"measure":46,"description":47,"timeFrame":48},"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.","Exit from operating room and up to 30 days post-procedure.",{"measure":50,"description":51,"timeFrame":48},"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.",{"measure":53,"description":54,"timeFrame":43},"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.",{"measure":56,"description":57,"timeFrame":58},"Blood Product Usage","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).",{"measure":60,"description":61,"timeFrame":62},"Procedure Time","Time from first incision to incision closure (hours).","During the index procedure.",{"measure":64,"description":65,"timeFrame":62},"Operating Room Time","Time from entry into the operating room suite until exit from the operating room suite (hours).",{"measure":67,"description":68,"timeFrame":62},"Percentage of Subjects Receiving Mitral Valve Replacement (MVR)","Percentage of subjects receiving mitral valve replacement during the index procedure.",{"measure":70,"description":71,"timeFrame":43},"Composite Effectiveness Endpoint","Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation.",{"measure":73,"description":74,"timeFrame":75},"Discharged to Home vs Other Facility","Discharge disposition following hospitalization, including discharge to home versus another facility.","At hospital discharge (an average of 4 days following the index procedure).",{"measure":77,"description":78,"timeFrame":79},"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.","Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.",{"measure":81,"description":82,"timeFrame":83},"Mitral Regurgitation Grade","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.",{"measure":85,"description":86,"timeFrame":83},"Left Ventricular End Diastolic Diameter (LVEDD)","Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).",{"measure":88,"description":86,"timeFrame":83},"Left Ventricular End Systolic Diameter (LVESD)",{"measure":90,"description":91,"timeFrame":83},"Left Ventricular End Diastolic Volume (LVEDV)","Measured by transthoracic echocardiogram (mL).",{"measure":93,"description":91,"timeFrame":83},"Left Ventricular End Systolic Volume (LVESV)",{"measure":95,"description":96,"timeFrame":83},"Left Ventricular Ejection Fraction (LVEF)","Measured by transthoracic echocardiogram (%).",{"measure":98,"description":91,"timeFrame":83},"Left Atrial Volume",{"measure":100,"description":86,"timeFrame":83},"Mitral Annular Septal-Lateral Dimension",{"measure":102,"description":103,"timeFrame":83},"Right Ventricular Systolic Pressure (RVSP)","Measured by transthoracic echocardiogram (mmHg).",{"measure":105,"description":103,"timeFrame":83},"Mitral Valve Peak Gradient",{"measure":107,"description":103,"timeFrame":83},"Mitral Valve Mean Gradient",{"measure":109,"description":82,"timeFrame":83},"Tricuspid Valve Regurgitation (TVR) Grade",{"measure":111,"description":112,"timeFrame":83},"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).",{"measure":114,"description":115,"timeFrame":116},"Ventilation Duration","Total ventilation duration following the index procedure (hours).","At extubation (an average of 2 hours following the index procedure).",{"measure":118,"description":119,"timeFrame":120},"Intensive Care Unit Length of Stay","Total intensive care unit length of stay following the index procedure (hours).","At ICU discharge (an average of 1 day following the index procedure).",{"measure":122,"description":123,"timeFrame":75},"Hospital Length of Stay","Total hospital length of stay following the index procedure (days).","ALL","21 Years",null,false,{"inclusion":129,"exclusion":134,"raw_text":148},[130,131,132,133],"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.",[135,136,137,138,139,140,141,142,143,144,145,146,147],"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 \\\u003C30% 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.","Inclusion Criteria:\n\n* Age 21 years or older.\n* Presence of severe degenerative mitral regurgitation confirmed by echocardiography.\n* Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension.\n* Ability to provide informed consent and willingness to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Functional mitral regurgitation.\n* Severe mitral annular or leaflet calcification.\n* Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation).\n* Left ventricular ejection fraction \\\u003C30% or severe right ventricular dysfunction.\n* Requirement for concomitant cardiac surgery.\n* Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).\n* Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).\n* Hemodynamic instability or cardiogenic shock at the time of enrollment.\n* Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.\n* Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.\n* Pregnancy, lactation, or planned pregnancy during the study period.\n* Participation in another investigational device or drug study that could interfere with outcomes.\n* Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.",[150,151],"ADULT","OLDER_ADULT",[153],{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":158,"contacts":159,"geoPoint":172},"Johns Hopkins Hospital","Baltimore","Maryland","21287","United States",[160,165,169],{"name":161,"role":162,"phone":163,"email":164},"Lisa Fornaresio, PhD","CONTACT","443-927-3984","lisa.fornaresio@jhmi.edu",{"name":166,"role":162,"phone":167,"email":168},"Rachael Quinn, PhD","410.955.2800","rquinn17@jhmi.edu",{"name":170,"role":171},"James S. Gammie, MD","PRINCIPAL_INVESTIGATOR",{"lat":173,"lon":174},39.29038,-76.61219,[176,178],{"name":161,"role":162,"phone":177,"email":164},"443.927.3984",{"name":166,"role":162,"phone":167,"email":168},[180],{"name":181,"affiliation":13,"role":171},"James Gammie, MD",[],[],{"nct_id":4,"conditions":185,"biomarkers":187},[186],"Mitral Valve Insufficiency",[],{"nct_id":4,"found":15,"summary":189,"prompt_version":199},{"design":190,"status":191,"heading":192,"summary":193,"follow_up":194,"word_count":195,"commitments":196,"compensation":197,"drugs_mentioned":198},"This is an interventional study planning to enroll 175 participants. The study is assessing a device called TRANSOM.","completed","Transventricular Off-pump Mitral Valve Repair (TRANSOM) for Mitral Regurgitation","This study is testing a new, less invasive way to repair a heart valve called the mitral valve. This procedure, called TRANSOM, helps people with severe mitral regurgitation (when the mitral valve doesn't close properly, causing blood to leak backward). Instead of a large incision, TRANSOM uses a small cut between the ribs and repairs the valve while your heart is still beating. The study aims to see how safe TRANSOM is within 30 days and how well it prevents problems like continued leakage or needing another surgery for up to one year. You might be able to join if you are 21 or older, have severe mitral regurgitation, and your valve anatomy is suitable for this repair. The current recruitment status is unclear.","Participants will be followed for safety for about 30 days or until hospital discharge. Effectiveness will be measured for one year after the procedure.",124,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]