NeoChord TACT Post-Market Surveillance Registry

N/ACompletedNCT01784055

NeoChord126 enrolled

Overview

To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

Study Type

OBSERVATIONAL

Enrollment

126

Conditions

Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Grade 3+ or 4+ mitral valve regurgitation 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

Locations (7)

Bordeaux Heart University Hospital (CHU)

Bordeaux, France

Herzzentrum Dresden

Dresden, Germany

Asklepios Hospital St. Georg

Hamburg, Germany

University Medical Center Hamburg

Hamburg, Germany

Outcomes

Primary Outcomes

Procedure Success

To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure

Time frame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.