Clinical trial NCT04190602: Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
Official title: The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Mitral Valve Disease
Mitral Valve Insufficiency
Mitral Valve Prolapse
Heart Valve Diseases
Keywords: NeoChord
DS1000
Artificial Chordae
Mitral Valve Repair
Lead sponsor: NeoChord
Sponsor class: INDUSTRY
First posted: 2019-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Mitral Regurgitation Following the Index Procedure
timeFrame: Completion of Index Procedure
Secondary outcomes:
measure: Level of Mitral Regurgitation at 3-6 Months
timeFrame: 3-6 Months
measure: Level of Mitral Regurgitation at 1 Year
timeFrame: 1 Year
measure: Level of Mitral Regurgitation at 2 Years
timeFrame: 2 Years
measure: Level of Mitral Regurgitation at 3 Years
timeFrame: 3 Years
measure: Level of Mitral Regurgitation at 4 Years
timeFrame: 4 Years
measure: Level of Mitral Regurgitation at 5 Years
timeFrame: 5 Years
Other outcomes:
measure: Freedom from Mitral Valve Re-intervention
timeFrame: From enrollment until date of mitral valve reintervention, up to 5 years
measure: Freedom from All-Cause Mortality
timeFrame: From enrollment until date of death, up to 5 years
Locations:
city: Bonn
country: Germany
facility: University of Bonn
city: Frankfurt
country: Germany
facility: CVC Frankfurt
city: Mainz
country: Germany
facility: University of Mainz
city: Athens
country: Greece
facility: Hippokration Hospital
city: Zurich
country: Switzerland
facility: Triemli Hospital
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Andres Beiras Fernandez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: