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European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation

NCT05425628 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-06-21

No results posted yet for this study

Summary

Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.

Conditions

  • Mitral Valve Insufficiency
  • Mitral Valve Prolapse
  • Degenerative
  • Mitral Regurgitation
  • Heart Valve Diseases
  • Heart Diseases
  • Cardiovascular Diseases

Interventions

DEVICE

NeoChord Transcatheter Mitral Repair System (or "NeoChord System")

The NeoChord Transcatheter Mitral Repair System is a system of delivery devices and implantable Neochordae and Anchor. The system is designed to percutaneously deliver and deploy the implantable ePTFE sutures, "Neochordae" as artificial chordae at the mitral valve and connect them to the implantable ventricular anchor, "Anchor", using a catheter based system placed into the left side of the heart through the interatrial septum.

Sponsors & Collaborators

  • NeoChord

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-09-01
Completion
2023-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425628 on ClinicalTrials.gov