Active — Not RecruitingNot Applicable

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

United States585 participantsStarted 2016-11-03

Plain-language 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).

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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.

Timeframe: 1 year

Trial details

NCT IDNCT02803957

SponsorNeoChord

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01

View on ClinicalTrials.gov More Mitral Valve Insufficiency trials