Valve Durability Registry
Research type
Research Study
Full title
EORP Valve Durability Registry
IRAS ID
259562
Contact name
Bernard Prendergast
Contact email
Sponsor organisation
European Society of Cardiology
Clinicaltrials.gov Identifier
NA , NA
Duration of Study in the UK
5 years, 10 months, 1 days
Research summary
This is an international, longitudinal multicentre, observational study in European countries. The registry will evaluate patients who underwent TAVI in 2014 and beforehand with any device available at that time.
Phase 1:
All patients who underwent TAVI over 5 years ago (e.g. in 2014 and beforehand) and who are still alive will be evaluated clinically and with 2D echocardiography during a 4-6 month period following enrolment of the Centre in the registry. Ehocardiographic examinations will be sent to the Echo Core Laboratory for central assessment. This exercise will provide information on different cohorts of patients >5, 6, 7, 8, 9, 10 years following the procedure.Phase 2:
All patients evaluated in Phase 1 who were <80 years of age at the time of TAVI will
undergo annual clinical and echocardiographic evaluation for a further 5 years (until
2024). Echocardiographic examinations performed at each time point will be sent to the Echo Core Laboratory for central assessment. Since this population will be smaller, recruitment will be extended to patients who underwent TAVI up to (and including) end of 2014. Recruitment will be performed in a consecutive manner during a period of 4-6 month recruitment period in each centre, without any limit to the maximum number of patients included. Standard management of patients currently performed in routine clinical practice will be followed. Drug prescriptions and indications to perform diagnostic/therapeutic procedures will be completely left to the participating cardiologists.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0100
Date of REC Opinion
18 Mar 2019
REC opinion
Further Information Favourable Opinion