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

Launched by NEOCHORD · Dec 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a device called the NeoChord Artificial Chordae Delivery System, which is used to treat certain heart valve problems, specifically degenerative mitral valve disease. Mitral valve disease can lead to a condition called mitral regurgitation, where the heart's mitral valve doesn't close properly, causing blood to flow backward. The goal of the study is to see how patients do five years after they receive this treatment.

To participate in this trial, individuals should be between the ages of 65 and 74 and have moderate to severe mitral regurgitation. However, people with certain complications, like heavily calcified valves or active infections, cannot join. Those who are eligible can expect to be monitored over a five-year period to evaluate the effectiveness and safety of the NeoChord device. It’s important to know that this study is currently recruiting participants, and it aims to gather valuable data to help improve treatment options for heart valve diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
• • Study procedure completed after 31 December 2016
• Exclusion Criteria:
• • Heavily calcified valves
• • Valvular retraction with severely reduced mobility
• • Active bacterial endocarditis
• • Complex mechanism of MR (leaflet perforation, etc.)
• • Significant tethering of leaflets
• • Inflammatory valve disease