Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR

ConditionMitral Valve Regurgitation (Degenerative or Functional)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHVR Cardio Oy

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Oxygen dependent for COPD

Active or suspected endocarditis

Severe symptomatic carotid stenosis

Has undergone heart transplantation.

Trial design

Design model

Single group

Treatments tested in this trial

Transcatheter Mitral Valve Repair
Device
Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation

Treatment groups

5 Participants

are divided into 1 treatment group

Group A: Single ArmOther 1 intervention

Trial outcomes

Primary outcomes

Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).

Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met: 1. The patient is alive. 2. There was successful access, delivery, and retrieval of the device delivery system. 3. The first intended device was successfully deployed and correctly positioned. 4. There was freedom from emergency surgery or reintervention related to the device or access procedure.

Time frame

Periprocedural

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HVR Cardio Oy

Lead sponsor

Source ClinicalTrials.gov

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