PFO PAS
Research type
Research Study
Full title
Amplatzer™ PFO Occluder and Amplatzer™ Talisman™ PFO Occluder Post Approval Study (PFO PAS)
IRAS ID
324008
Contact name
Rebecca Malpass
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
The purpose of this research study is to collect additional information on the safety and effectiveness of the commercially approved Amplatzer PFO Occluder and Amplatzer Talisman PFO Occluder.
The Amplatzer PFO Occluder and Amplatzer Talisman PFO Occluders have received regulatory approval to be used commercially in Europe and are currently available for commercial use in different European countries, including the UK. They are not investigational devices and the patients to be approached for this study will have already been identified to receive one of these devices due to clinical need.
This study will allow Abbott to continue to monitor the long-term use of the devices for a period of up to 5 years.
The study requires clinic visits at 1 month, 6 months, and 12 months post procedure; and telephone follow-up at 2, 3, 4, and 5 years post procedure.
REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0208
Date of REC Opinion
19 Apr 2023
REC opinion
Further Information Favourable Opinion