Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Recruiting
N/A
Interventional Study
Mitral Valve Regurgitation (Degenerative or Functional)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 5 (estimated)
- Sponsor
- HVR Cardio Oy · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.
Trial Locations
Loading…
Loading trial locations…
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 sympt…
Contacts