CompletedNot Applicable

Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)

Georgia, Paraguay, Serbia7 participantsStarted 2022-03-18

Plain-language summary

A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.

Who can participate

Age range

30 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of moderate to severe Mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. * Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating physician and the patient eligibility committee. * Degenerative mitral valve disease. * Patients who have been evaluated and no contraindication has been found for open heart surgery OR candidates for mitral valve surgery who, according to current guidelines, are at elevated surgical risk AND for whom transcatheter therapy is deemed more appropriate than open heart surgery in the judgement of the Site Heart Team. Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization * Creatine Kinase-MB (CK-MB) obtained within prior 14 days \> local laboratory Upper Limit of Normal (ULN) * Age \<30/40 or \> 85 years * Presence of any of the following: * Estimated pulmonary artery systolic pressure (PASP) \> 70 mmHg assessed by site based on echocardiography or right heart catheterization * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, ischemic or non-ischemic Functional mitral regurgitation or any other structural heart disease causing heart failure * Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) * Hemodynamic instability requiring inotropic support or mechanical heart assistance * Hemodynamic ins…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.

Timeframe: Procedure through 30 days post procedure

Freedom from device-related Major Adverse Events (MAE), defined as a combined clinical endpoint of death, reoperation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke or renal failure

Timeframe: Procedure through 30 days post procedure

Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle

Timeframe: Procedure

Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.

Timeframe: Procedure through 30 days post procedure

Trial details

NCT IDNCT04281940

SponsorPipeline Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-07

View on ClinicalTrials.gov More Degenerative Mitral Valve Disease trials

Who can participate

Age range

30 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.

Timeframe: Procedure through 30 days post procedure

Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle

Timeframe: Procedure

Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.

Timeframe: Procedure through 30 days post procedure