NCT01784055

Brief Summary

To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

Trial Health

93
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
5 countries

7 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 31, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 2, 2018

Completed
Last Updated

April 2, 2018

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

January 31, 2013

Results QC Date

August 31, 2017

Last Update Submit

August 31, 2017

Conditions

Mitral Valve InsufficiencyHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Keywords

NeoChordDS1000Mitral ValveMitral Valve RegurgitationMRMitral Valve RepairMitral Valve ProlapseArtificial Chordae

Outcome Measures

Primary Outcomes (1)

  • Procedure Success

    To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure

    The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement

You may qualify if:

  • Grade 3+ or 4+ mitral valve regurgitation

You may not qualify if:

  • Heavily calcified valves
  • Valvular retraction with severely reduced mobility
  • Active bacterial endocarditis
  • Complex mechanism of MR (leaflet perforation, etc.)
  • Significant tethering of leaflets
  • Inflammatory valve disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bordeaux Heart University Hospital (CHU)

Bordeaux, France

Location

Herzzentrum Dresden

Dresden, Germany

Location

Asklepios Hospital St. Georg

Hamburg, Germany

Location

University Medical Center Hamburg

Hamburg, Germany

Location

University of Padova Medical School

Padua, 35127, Italy

Location

Vilniaus Universiteto ligonines Santariskiu

Vilnius, Lithuania

Location

Universitätsspital Basel

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesMitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve Prolapse

Results Point of Contact

Title
Lori E Adels, PhD
Organization
NeoChord, Inc.
ladels@neochord.com
1-952-698-7804

Study Officials

  • Joerg Seeberger, MD

    Leipzig University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 5, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 2, 2018

Results First Posted

April 2, 2018

Record last verified: 2017-08

Locations

IT(1)DE(3)LI(1)FR(1)CH(1)