Mitral Valve (MV) RegurgitationTRANSOMNCT07726173
Transventricular Off-pump Mitral Valve Repair
A study testing TRANSOM in people with Mitral Valve (MV) Regurgitation, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Valve (MV) Regurgitation
- What is being tested?
- TRANSOM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Lisa Fornaresio, PhD, 443-927-3984, lisa.fornaresio@jhmi.edu
Rachael Quinn, PhD, 410.955.2800, rquinn17@jhmi.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Valve (MV) Regurgitation
- Being tested
- TRANSOM
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRANSOMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transventricular off-pump mitral valve repair | Experimental | Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation. Receives: Device: TRANSOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year post-index procedure.
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Perioperative through hospital discharge (an average of 4 days following the index procedure).
Procedure Time
Time from first incision to incision closure (hours).
Measured: During the index procedure.
Operating Room Time
Time from entry into the operating room suite until exit from the operating room suite (hours).
Measured: During the index procedure.
Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
Percentage of subjects receiving mitral valve replacement during the index procedure.
Measured: 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.
Measured: 1 year post-index procedure.
Discharged to Home vs Other Facility
Discharge disposition following hospitalization, including discharge to home versus another facility.
Measured: 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.
Measured: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
Mitral Regurgitation Grade
Measured by transthoracic echocardiogram.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At hospital discharge (an average of 4 days following the index procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start8 Jun 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve (MV) RegurgitationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Gammie, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726173
- Sponsor's protocol ID
- IRB00416988
- Acronym
- TRANSOM
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transventricular Off-pump Mitral Valve Repair (TRANSOM)
- ClinicalTrials.gov ID
- NCT07726173
- Acronym / sponsor ID
- TRANSOM / IRB00416988
- Conditions
- Mitral Valve (MV) Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transventricular off-pump mitral valve repair | Experimental | Device: TRANSOMParticipants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRANSOMTRANSOM 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. | Device | Transventricular off-pump mitral valve repair |
Primary outcome
Primary Safety Endpoint: Composite Freedom from Major Adverse Events
Time frame: 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
Time frame: 1 year post-index procedure.
Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
26 secondary outcomes
Technical Success
Time frame: Exit from operating room and up to 30 days post-procedure.
Procedural Success
Time frame: Exit from operating room and up to 30 days post-procedure.
Patient Success
Time frame: 1 year post-index procedure.
Blood Product Usage
Time frame: Perioperative through hospital discharge (an average of 4 days following the index procedure).
Procedure Time
Time frame: During the index procedure.
Operating Room Time
Time frame: During the index procedure.
Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
Time frame: During the index procedure.
Composite Effectiveness Endpoint
Time frame: 1 year post-index procedure.
Discharged to Home vs Other Facility
Time frame: At hospital discharge (an average of 4 days following the index procedure).
New York Heart Association (NYHA) Functional Class
Time frame: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
Mitral Regurgitation Grade
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)
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)
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)
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)
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)
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
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
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)
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
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
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
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
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
Time frame: At extubation (an average of 2 hours following the index procedure).
Intensive Care Unit Length of Stay
Time frame: At ICU discharge (an average of 1 day following the index procedure).
Hospital Length of Stay
Time frame: At hospital discharge (an average of 4 days following the index procedure).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Gammie, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRANSOM in people with Mitral Valve (MV) Regurgitation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Fornaresio, PhD (443.927.3984, lisa.fornaresio@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Composite Freedom from Major Adverse Events (time frame: 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.