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OpenTrials
Completed

NCT Number: NCT01784055

NeoChord TACT Post-Market Surveillance Registry

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

Completed

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Key information

Conditions

Mitral Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heart Valve Prolapse Mitral Valve Prolapse

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux Heart University Hospital (CHU), Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Procedure Success

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

    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

Sponsors and collaborators

Lead sponsor

NeoChord

Industry

Registry information

Official study title

Post-Market Surveillance Registry for the NeoChord DS1000

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2013
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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