Mitral Valve Repair With the Chord-X System: A Long Term Evaluation

Part of paid clinical trials in Edgewood, Kentucky.

Sponsor
Artivion Inc.
Study ID
NCT07413926
Status
Not Yet Recruiting

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Conditions

  • Mitral Regurgitation (MR)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chord-X system implant — DEVICE
    Patients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022

Study Details

The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data (out to 10 years). Collecting patient health information over time can help to supplement and improve the care of patients in the future. Participants will: Agree to the collection of their past medical history, and the details of their mitral repair surgery with the Chord-X system, including results of the follow-up examinations after implantation Visit the clinic for the routinely scheduled follow-up examination appointments

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2034
Completion
Jun 30, 2034

Study Design

Enrollment
110 participants (estimated)

Arms

  • Arm: Patients who underwent mitral repair with Chord-X system beginning in January 2022
    all patients who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated, beginning in January 2022, will be approached for participation in the study.

Primary Outcome Measure

Recurrent Mitral Regurgitation [ Time Frame: The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Elizabeth HealthcareEdgewoodKentucky41017
Cynthia Mulcahy
[email protected]

Find similar trials in Edgewood, KY

By research site
St. Elizabeth Healthcare· Edgewood, KY

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