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Completed

NCT Number: NCT01777815

Safety and Performance Study of the NeoChord Device

The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.

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Key information

Conditions

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

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Skejby, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >= 18 and < 80 years
  • Candidate for surgical mitral valve repair or replacement
  • Isolated posterior leaflet prolapse
  • Moderate to severe or severe mitral valve regurgitation that is degenerative in nature

Exclusion criteria

  • Anterior or bi-leaflet prolapse
  • Functional or ischemic MR
  • NYHA Class IV
  • Complex mechanism of MR (leaflet perforation, etc)
  • Significant tethering of leaflets toward LV apex
  • Severely calcified mitral valve annulus
  • Inflammatory valve disease
  • Severe LV dilation

Treatment and study plan

NeoChord DS1000 Artificial Chordae Delivery System

Device

Primary outcomes

  1. Procedural Success

    Time frame: 30 days

    The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days

Secondary outcomes

  1. Procedural Safety

    Time frame: 30 days

    the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation > 48 hours, procedure-related transfusion of > 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days.

Sponsors and collaborators

Lead sponsor

NeoChord

Industry

Registry information

Official study title

Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation

Acronym: TACT

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Jan 29, 2013
Registry last updated
Sep 25, 2014

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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