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Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

RECRUITINGN/ASponsored by NeoChord
Actively Recruiting
PhaseN/A
SponsorNeoChord
Started2016-11-03
Est. completion2022-07
Eligibility
Age21 Years+
Healthy vol.Accepted
Locations18 sites
View on ClinicalTrials.gov →

NCT02803957

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).

Eligibility

Age: 21 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseMitral Valve Insufficiency

Locations18 sites

Sutter Health/Alta Bates Summitt Medical Center
Oakland, California, 94609
Junaid Khan, MD
Mercy General Hospital
Sacramento, California, 95819
Frank Slachman, MD
Stanford University
Stanford, California, 94305
Jack Boyd, MD
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Christian Shults, MD
Florida Hospital
Orlando, Florida, 32803

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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