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Active, Not Recruiting

NCT Number: NCT02803957

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mitral Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy General Hospital, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is a candidate for mitral valve repair with cardiopulmonary bypass
  • Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
  • Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
  • Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
  • Anatomic and general suitability

Exclusion criteria

  • Prior mitral valve surgery
  • Concomitant cardiac procedures
  • Other cardiac procedures within 3 months

Treatment and study plan

NeoChord DS1000

Device

Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000

Surgical Mitral Valve Repair

Device

Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.

Primary outcomes

  1. Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.

    Time frame: Post-operative Day (POD) 30

  2. Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

NeoChord

Industry

Registry information

Official study title

Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair

Acronym: ReChord

Important dates

Study start
2016
Primary completion
2021
Study completion
2027
First posted
Jun 17, 2016
Registry last updated
Apr 8, 2026

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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