Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Not Applicable

Recruiting

• Conditions: Mitral Valve Insufficiency

• Registration Number: NCT02803957
• Lead Sponsor: NeoChord

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Study Start: 2016-11-03
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-05
• Primary Completion: 2022-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 585

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

Sutter Health/Alta Bates Summitt Medical Center; 🇺🇸 Oakland, California, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Franciscan Health; 🇺🇸 Indianapolis, Indiana, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mount Sinai, Icahn School of Medicine; 🇺🇸 New York, New York, United States

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