Clinical trial NCT02803957: Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
Official title: Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Insufficiency
Keywords: Degenerative
Mitral Regurgitation
Lead sponsor: NeoChord
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 585
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Sutter Health/Alta Bates Summitt Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Indianapolis
country: United States
facility: Franciscan Health
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Mount Sinai, Icahn School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: St. Thomas
state: Tennessee
city: Plano
country: United States
facility: Baylor - Plano
state: Texas
city: Winchester
country: United States
facility: Valley Health System | Virginia
state: Virginia
Study officials:
References: