NCT02803957

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Nov 2016Jan 2027

First Submitted

Initial submission to the registry

May 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 3, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

April 8, 2026

Status Verified

March 1, 2023

Enrollment Period

4.2 years

First QC Date

May 9, 2016

Last Update Submit

April 2, 2026

Conditions

Mitral Valve Insufficiency

Keywords

DegenerativeMitral Regurgitation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000

Device: NeoChord DS1000

Control Group

ACTIVE COMPARATOR

Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair

Device: Surgical Mitral Valve Repair

Interventions

NeoChord DS1000DEVICE

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

Treatment Group
Surgical Mitral Valve RepairDEVICE

Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.

Control Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior mitral valve surgery
  • Concomitant cardiac procedures
  • Other cardiac procedures within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30339, United States

Location

Franciscan Health

Indianapolis, Indiana, 46237, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mount Sinai, Icahn School of Medicine

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Pinnacle Health

Harrisburg, Pennsylvania, 17110, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

St. Thomas

Nashville, Tennessee, 37205, United States

Location

Baylor - Plano

Plano, Texas, 75093, United States

Location

Valley Health System | Virginia

Winchester, Virginia, 22601, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

June 17, 2016

Study Start

November 3, 2016

Primary Completion

January 1, 2021

Study Completion (Estimated)

January 1, 2027

Last Updated

April 8, 2026

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(14)