Status:
COMPLETED
PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
Lead Sponsor:
IRCCS Ospedale San Raffaele
Collaborating Sponsors:
Centro Cardiologico Monzino
University Hospital Padova
Conditions:
Patent Foramen Ovale
Stroke, Cryptogenic
Eligibility:
All Genders
18+ years
Brief Summary
Patent foramen ovale (PFO) has been associated with cryptogenic stroke and transient ischemic attack (TIA) in young adults. Evidence from randomized clinical trials (RCT) has shown that transcatheter...
Detailed Description
The PROLONG (PFO Transcatheter Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter registry. It includes 1,360 subjects who underwent transcatheter patent fora...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Confirmed Patent Foramen Ovale (PFO);
- Transcatheter Patent Foramen Ovale (PFO) closure with an Occluder device;
- PFO closure procedure performed between 1999 and 2013.
Exclusion
- Age \< 18 years;
- Previous surgical or transcatheter PFO closure;
- Patients without follow-up data available.
Key Trial Info
Start Date :
January 1 1999
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
1360 Patients enrolled
Trial Details
Trial ID
NCT06504121
Start Date
January 1 1999
End Date
June 1 2024
Last Update
July 16 2024
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