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NCT Number: NCT04190602

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heart Valve Prolapse Mitral Valve Disease Mitral Valve Insufficiency Mitral Valve Prolapse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bonn, Bonn, Germany

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About this study

This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

NeoChord Artificial Chordae Delivery System, Model DS1000

Device

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.

Other names: NeoChord DS1000, DS1000

Primary outcomes

  1. Level of Mitral Regurgitation Following the Index Procedure

    Time frame: Completion of Index Procedure

    Level of mitral regurgitation per echocardiography

Secondary outcomes

  1. Level of Mitral Regurgitation at 3-6 Months

    Time frame: 3-6 Months

    Level of mitral regurgitation per echocardiography

  2. Level of Mitral Regurgitation at 1 Year

    Time frame: 1 Year

    Level of mitral regurgitation per echocardiography

  3. Level of Mitral Regurgitation at 2 Years

    Time frame: 2 Years

    Level of mitral regurgitation per echocardiography

  4. Level of Mitral Regurgitation at 3 Years

    Time frame: 3 Years

    Level of mitral regurgitation per echocardiography

  5. Level of Mitral Regurgitation at 4 Years

    Time frame: 4 Years

    Level of mitral regurgitation per echocardiography

  6. Level of Mitral Regurgitation at 5 Years

    Time frame: 5 Years

    Level of mitral regurgitation per echocardiography

Other outcomes

  1. Freedom from Mitral Valve Re-intervention

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

  2. Freedom from All-Cause Mortality

    Time frame: From enrollment until date of death, up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandar Jonkers

CONTACT

[email protected]

+31 610740977

Sponsors and collaborators

Lead sponsor

NeoChord

Industry

Registry information

Official study title

The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

Acronym: AcChord

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Dec 9, 2019
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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