Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Mitral Valve Insufficiency Clinical Trial

— ReChord  

Official title:

Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02803957
• Other study ID #: NeoChord: PR-610405-100
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2016
• Est. completion date: July 2027

Study information

• Verified date: December 2019
• Source: NeoChord
• Contact: David H Adams, MD
• Phone: 212-659-6820
• Email: david.adams[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 585
• Est. completion date: July 2027
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• NeoChord DS1000
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
• Surgical Mitral Valve Repair
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	The Christ Hospital	Cincinnati	Ohio
United States	Pinnacle Health	Harrisburg	Pennsylvania
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Franciscan Health	Indianapolis	Indiana
United States	St. Thomas	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai, Icahn School of Medicine	New York	New York
United States	Sutter Health/Alta Bates Summitt Medical Center	Oakland	California
United States	Florida Hospital	Orlando	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Baylor - Plano	Plano	Texas
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	Valley Health System | Virginia	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
NeoChord

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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