Transventricular Off-pump Mitral Valve Repair (TRANSOM)

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve (MV) Regurgitation
• Intervention / Treatment: Device: TRANSOM

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.

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Fornaresio, PhD; Phone Number: 443.927.3984; Email: lisa.fornaresio@jhmi.edu
• Study Contact Backup: Name: Rachael Quinn, PhD; Phone Number: 410.955.2800; Email: rquinn17@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Lisa Fornaresio, PhD; Phone Number: 443-927-3984; Email: lisa.fornaresio@jhmi.edu
      • Contact: Rachael Quinn, PhD; Phone Number: 410.955.2800; Email: rquinn17@jhmi.edu
      • Principal Investigator: James S. Gammie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.	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.	1 year post-index procedure.
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).
Procedure Time	Time from first incision to incision closure (hours).	During the index procedure.
Operating Room Time	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)	Percentage of subjects receiving mitral valve replacement during the index procedure.	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.	1 year post-index procedure.
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).
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.
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.
Left Ventricular End Diastolic Diameter (LVEDD)	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)	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)	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)	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)	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	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	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)	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	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	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	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	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	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	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	Total hospital length of stay following the index procedure (days).	At hospital discharge (an average of 4 days following the index procedure).

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: James Gammie, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: IRB00416988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes