Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Launched by NEOCHORD · Jun 14, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Neochord DS1000 System, which is designed to help repair the mitral valve in the heart. The trial aims to compare this device's safety and effectiveness to standard surgical methods that use a heart-lung machine (called cardiopulmonary bypass) for patients with mitral valve insufficiency—a condition where the valve does not close properly, leading to blood leakage. Participants will be divided into two groups: one will receive the new device without using the heart-lung machine, and the other will have the traditional surgery.

To qualify for this trial, participants must be adults with moderate to severe mitral valve leakage and specific types of valve issues that can be addressed with surgery. They should not have had prior heart surgery or other heart procedures recently. If someone joins the study, they can expect to undergo a mitral valve repair, and their progress will be monitored closely to ensure their safety and the effectiveness of the treatment. This trial is currently recruiting participants, and it welcomes individuals of all genders aged 70 and older.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Is a candidate for mitral valve repair with cardiopulmonary bypass
• • Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
• • Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
• • Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
• • Anatomic and general suitability
• Exclusion Criteria:
• • Prior mitral valve surgery
• • Concomitant cardiac procedures
• • Other cardiac procedures within 3 months