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

A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation

This will test the CathHELIX transcatheter mitral annuloplasty device to see if it reduces moderate-to-severe or severe functional mitral regurgitation and improves symptoms in adults with NYHA class II–IV and LVEF ≥30%.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: HVR Cardio Oy (industry)
• Locations: 2 sites (Tbilisi, Georgia and 1 other locations)
• Trial ID: NCT07188233 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with functional (secondary) mitral regurgitation graded moderate-to-severe (3+) or severe (4+), symptomatic (NYHA II–IV), and LVEF ≥30% who have suitable mitral anatomy and coronary sinus alignment are the intended candidates.

Not a fit: Patients with severe annular or leaflet calcification, active or suspected endocarditis, oxygen-dependent COPD, prior heart transplant, severe symptomatic carotid stenosis, or coronary sinus anatomy that precludes device placement are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the device could reduce mitral regurgitation and improve symptoms and quality of life while offering a less invasive option than surgery for selected patients.

How similar studies have performed: Edge-to-edge transcatheter repair (for example MitraClip) has shown benefit in selected functional MR patients, but transcatheter annuloplasty devices like CathHELIX are less established and have limited published outcomes so far.

Eligibility criteria

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 this trial is running

Tbilisi, Georgia and 1 other locations

• 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

Conditions: Mitral Valve Regurgitation