Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
NCT07413926 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 110
Last updated 2026-02-20
Summary
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
Conditions
- Mitral Regurgitation (MR)
Interventions
- DEVICE
-
Chord-X system implant
Patients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022
Sponsors & Collaborators
-
Artivion Inc.
lead INDUSTRY
Principal Investigators
-
Joseph Zacharias, MD
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2034-03-31
- Completion
- 2034-06-30
- FDA Device
- Yes
Countries
- United States
- Italy
- United Kingdom
Study Locations
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