Five-Year Outcomes Study of the NeoChord Artificial Chordae System for Treating Degenerative Mitral Valve Disease

What this Trial Is About

Researchers are observing the long-term outcomes over five years in participants with degenerative mitral valve disease who have been treated using the NeoChord Artificial Chordae System, Model DS1000. This study focuses on patients with moderate to severe mitral valve regurgitation, aiming to gather real-world data in a post-market setting without introducing additional invasive procedures beyond standard treatment. The study is a single-arm, multicenter, observational registry allowing both prospective and retrospective enrollment. Participants have undergone mitral valve repair using the NeoChord device, which is designed to place artificial chordae when natural chordae tendinae are damaged due to degenerative valve disease. No extra invasive or burdensome examinations beyond those required for routine mitral valve repair are involved. Participants will be monitored primarily for the level of mitral regurgitation following their procedure. Secondary assessments will track mitral regurgitation levels at intervals up to five years after treatment. Data collection aligns with standard care visits, minimizing extra burden. The study will help assess the devices performance and patient outcomes over an extended period in routine clinical practice.

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System