The AcChord Study PR-610414-101 Rev. B1
Research type
Research Study
Full title
The AcChord Study A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
IRAS ID
291118
Contact name
Rashmi Yadav
Contact email
Sponsor organisation
NeoChord
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Clinicaltrials.gov, NCT04190602
Duration of Study in the UK
6 years, 9 months, 31 days
Research summary
The objective of the AcChord Study is to evaluate the 5-year outcomes of patients treated with the NeoChord Artificial Chordae Delivery System, Model DS1000.
The device is intended to be used in patients for repair of mitral valve regurgitation due to chordal elongation and rupture resulting in mitral valve prolapse. Patients with a treatment decision for treatment with the NeoChord Artificial Chordae Delivery System qualify for study participation and will be approached by the investigator. Patients can be enrolled if the treatment has been performed (retrospective) or has been scheduled (prospective).
The study is carried out in centres of excellence in UK, Germany, Austria, Italy, Greece, Switzerland. The study is planned to be completed by Dec 2027 with a 5 year follow up per patient. Data of standard of care assessments will be collected as well as Quality-of-Live questionnaires at 4 time points.REC name
London - Bloomsbury Research Ethics Committee
REC reference
22/PR/0018
Date of REC Opinion
24 Feb 2022
REC opinion
Further Information Favourable Opinion