Search > Heart Valve Leak
30 Participants NeededMy employer runs this trial

CARLEN System for Heart Valve Leak

(ENHANCE EFS Trial)

Recruiting at 2 trial locations
JM
Overseen ByJennifer Mischke, VP of Regulatory and Clinical
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nyra Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.

Are You a Good Fit for This Trial?

This trial is for adults over 21 with moderate-to-severe or severe functional mitral valve regurgitation (a leaky heart valve) who still have symptoms despite taking the best available medications. Participants must be able to attend follow-up visits and be suitable for a minimally invasive heart procedure.

Inclusion Criteria

I am considered suitable for transcatheter mitral valve repair by my heart care team.
I have moderate-to-severe or severe mitral valve regurgitation.
This is a key eligibility criterion for the study.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • CARLEN System

Trial Overview

The study is testing the safety and performance of the CARLEN System, a new device designed to help fix leaking mitral heart valves using a catheter-based (minimally invasive) approach in people with significant symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CARLEN SystemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nyra Medical, Inc.

Lead Sponsor

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