NCT04190602

Brief Summary

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
3 countries

5 active sites

Status
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 Progress80%
Feb 2020Dec 2027

First Submitted

Initial submission to the registry

December 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 9, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

December 4, 2019

Last Update Submit

July 9, 2020

Conditions

Mitral RegurgitationMitral Valve DiseaseMitral Valve InsufficiencyMitral Valve ProlapseHeart Valve Diseases

Keywords

NeoChordDS1000Artificial ChordaeMitral Valve Repair

Outcome Measures

Primary Outcomes (1)

  • Level of Mitral Regurgitation Following the Index Procedure

    Level of mitral regurgitation per echocardiography

    Completion of Index Procedure

Secondary Outcomes (6)

  • Level of Mitral Regurgitation at 3-6 Months

    3-6 Months

  • Level of Mitral Regurgitation at 1 Year

    1 Year

  • Level of Mitral Regurgitation at 2 Years

    2 Years

  • Level of Mitral Regurgitation at 3 Years

    3 Years

  • Level of Mitral Regurgitation at 4 Years

    4 Years

  • +1 more secondary outcomes

Other Outcomes (2)

  • Freedom from Mitral Valve Re-intervention

    From enrollment until date of mitral valve reintervention, up to 5 years

  • Freedom from All-Cause Mortality

    From enrollment until date of death, up to 5 years

Interventions

NeoChord Artificial Chordae Delivery System, Model DS1000DEVICE

The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease.

Also known as: NeoChord DS1000, DS1000

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who meet the indications and are not contraindicated for treatment by the NeoChord Artificial Chordae Delivery System, Model DS1000.

You may qualify if:

  • Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
  • Study procedure completed after 31 December 2016

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 (5)

University of Bonn

Bonn, Germany

RECRUITING

CVC Frankfurt

Frankfurt, Germany

RECRUITING

University of Mainz

Mainz, Germany

RECRUITING

Hippokration Hospital

Athens, Greece

RECRUITING

Triemli Hospital

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Mitral Valve InsufficiencyMitral Valve ProlapseHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart Valve Prolapse

Study Officials

  • Andres Beiras Fernandez, MD PhD

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandar Jonkers

CONTACT

+31 610740977ajonkers@neochord.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 9, 2019

Study Start

February 9, 2020

Primary Completion

October 1, 2022

Study Completion (Estimated)

December 1, 2027

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)CH(1)DE(3)