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

Mitral Regurgitation Clinical Trial

— AcChord  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190602
• Other study ID #: PR-610414-101
• Status: Recruiting
• Start date: February 9, 2020
• Est. completion date: December 2027

Study information

• Verified date: July 2020
• Source: NeoChord
• Contact: Alexandar Jonkers
• Phone: +31 610740977
• Email: ajonkers[@]neochord.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2027
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• NeoChord Artificial Chordae Delivery System, Model DS1000
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.

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn
Germany	CVC Frankfurt	Frankfurt
Germany	University of Mainz	Mainz
Greece	Hippokration Hospital	Athens
Switzerland	Triemli Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
NeoChord

Countries where clinical trial is conducted

Germany,  Greece,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Freedom from Mitral Valve Re-intervention		From enrollment until date of mitral valve reintervention, up to 5 years
Other	Freedom from All-Cause Mortality		From enrollment until date of death, up to 5 years
Primary	Level of Mitral Regurgitation Following the Index Procedure	Level of mitral regurgitation per echocardiography	Completion of Index Procedure
Secondary	Level of Mitral Regurgitation at 3-6 Months	Level of mitral regurgitation per echocardiography	3-6 Months
Secondary	Level of Mitral Regurgitation at 1 Year	Level of mitral regurgitation per echocardiography	1 Year
Secondary	Level of Mitral Regurgitation at 2 Years	Level of mitral regurgitation per echocardiography	2 Years
Secondary	Level of Mitral Regurgitation at 3 Years	Level of mitral regurgitation per echocardiography	3 Years
Secondary	Level of Mitral Regurgitation at 4 Years	Level of mitral regurgitation per echocardiography	4 Years
Secondary	Level of Mitral Regurgitation at 5 Years	Level of mitral regurgitation per echocardiography	5 Years