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New treatment option for Mitral Valve Regurgitation (Degenerative or Functional)
Official title Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
ClinicalTrials.gov ID: NCT07188233
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tbilisi, Georgia, Georgia
- Vilnius, Lithuania, Lithuania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tbilisi, Georgia, Georgia; Vilnius, Lithuania, Lithuania. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.