Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02803957

Acronym

ReChord

Enrollment

585

Registered

2016-06-17

Start date

2016-11-03

Completion date

2027-01-01

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Insufficiency

Keywords

Degenerative, Mitral Regurgitation

Brief summary

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).

Interventions

DEVICENeoChord DS1000

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

DEVICESurgical Mitral Valve Repair

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.	Post-operative Day (POD) 30
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.	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026