Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

NARecruitingINTERVENTIONAL
Enrollment

585

Participants

Timeline

Start Date

November 3, 2016

Primary Completion Date

July 31, 2022

Study Completion Date

July 31, 2027

Conditions
Mitral Valve Insufficiency
Interventions
DEVICE

NeoChord DS1000

Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000

DEVICE

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.

Trial Locations (18)

10029

RECRUITING

Mount Sinai, Icahn School of Medicine, New York

10032

RECRUITING

Columbia University Medical Center, New York

15232

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

17033

WITHDRAWN

Penn State Milton S. Hershey Medical Center, Hershey

17110

RECRUITING

Pinnacle Health, Harrisburg

20010

RECRUITING

MedStar Washington Hospital Center, Washington D.C.

21287

RECRUITING

Johns Hopkins University, Baltimore

30339

RECRUITING

Piedmont Heart Institute, Atlanta

32803

WITHDRAWN

Florida Hospital, Orlando

37205

RECRUITING

St. Thomas, Nashville

45219

WITHDRAWN

The Christ Hospital, Cincinnati

46237

RECRUITING

Franciscan Health, Indianapolis

48109

RECRUITING

University of Michigan, Ann Arbor

75093

RECRUITING

Baylor - Plano, Plano

94305

RECRUITING

Stanford University, Stanford

94609

RECRUITING

Sutter Health/Alta Bates Summitt Medical Center, Oakland

95819

RECRUITING

Mercy General Hospital, Sacramento

Virginia

RECRUITING

"Valley Health System , Virginia"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NeoChord

INDUSTRY

NCT02803957 - Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair | Biotech Hunter | Biotech Hunter