Abbott SH Registry
Research type
Research Study
Full title
Abbott Structural Heart Device Registry
IRAS ID
346246
Contact name
Alain Fraisse
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
15 years, 3 months, 0 days
Research summary
The objective of the Abbott Structural Heart (SH) Registry is to confirm the safety and performance of Abbott’s SH devices in a post-market, real-world setting. Follow-up and data collection are intended to fulfill post-market clinical follow-up requirements of CE Mark.
This Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or standard-of-care procedures. The UK sites are being asked to offer people who have had a procedure with an 'Amplatzer' device to take part in this data collection study.
All patients who provide informed consent and undergo an implant procedure with an applicable Abbott SH device are eligible to participate in the Registry.
REC name
HSC REC A
REC reference
24/NI/0101
Date of REC Opinion
30 Sep 2024
REC opinion
Further Information Favourable Opinion