Mitral valve repair with the CathHELIX transcatheter annuloplasty system for functional mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with symptomatic functional mitral regurgitation graded 3+ or 4+ and left ventricular ejection fraction ≥30% will receive a percutaneous mitral annuloplasty procedure using the CathHELIX transcatheter system delivered to the mitral annulus. The intervention is intended to reshape or reduce the annular dimension via a transcatheter approach without open-heart surgery. Key enrollment exclusions include active endocarditis, oxygen-dependent COPD, severe mitral annular or leaflet calcification, prior heart transplantation, severe symptomatic carotid stenosis, or coronary sinus anatomy that prevents device placement. Procedures and follow-up occur at participating centers in Tbilisi, Georgia and Vilnius, Lithuania with clinical and imaging assessments to track regurgitation severity and symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Moderate to severe (3+) or severe (4+) functional mitral regurgitation
* Left ventricular ejection fraction ≥30%
* Symptomatic New York Heart Association (NYHA) Class II to IV).

Exclusion Criteria:

* Oxygen dependent for COPD
* Active or suspected endocarditis
* Severe symptomatic carotid stenosis
* Has undergone heart transplantation.
* Severe calcification of the mitral annulus or leaflets
* Coronary sinus anatomy that may preclude proper treatment with the device

Where it's running

• Tbilisi Heart and Vascular Clinic
  Tbilisi, Georgia, Georgia Recruiting
• Vilnius University Hospital, Santaros Klinikos, Public Institution
  Vilnius, Lithuania, Lithuania Recruiting

Study contacts

• Principal investigator: Vinayak Bapat — Abbott Northwestern and United Hospitals
• Study coordinator: Thomas Fleming
• Email: tom@hvrcardio.com
• Phone: 612 940 8037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.