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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNeoChord

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation

Study procedure completed after 31 December 2016

Disqualifiers

Heavily calcified valves

Valvular retraction with severely reduced mobility

Active bacterial endocarditis

Complex mechanism of MR (leaflet perforation, etc.)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Level of Mitral Regurgitation Following the Index Procedure

Level of mitral regurgitation per echocardiography

Time frame
Completion of Index Procedure

Secondary outcomes

1

Level of Mitral Regurgitation at 3-6 Months

Level of mitral regurgitation per echocardiography

Time frame
3-6 Months
2

Level of Mitral Regurgitation at 1 Year

Level of mitral regurgitation per echocardiography

Time frame
1 Year
3

Level of Mitral Regurgitation at 2 Years

Level of mitral regurgitation per echocardiography

Time frame
2 Years
4

Level of Mitral Regurgitation at 3 Years

Level of mitral regurgitation per echocardiography

Time frame
3 Years

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

Sponsors and contacts

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