Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (ReChord)

NeoChord

Status: Enrolling

Conditions: Mitral Valve Insufficiency

Treatments: Device: NeoChord DS1000; Device: Surgical Mitral Valve Repair

Study type: Interventional

Funder types: Industry

Identifiers

NCT02803957

NeoChord: PR-610405-100

Details and patient eligibility

About

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).

Enrollment: 585 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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585 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000

Treatment:

Device: NeoChord DS1000

Control Group

Active Comparator group

Description:

Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair

Treatment:

Device: Surgical Mitral Valve Repair