PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
NCT Number: NCT06504121
Acronym: PROLONG
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Patent Foramen Ovale|Stroke, Cryptogenic|Transient Ischaemic Attack Due to Embolism|Atrial Fibrillation New Onset
Interventions: DEVICE: Septal Occluder Device
Sponsor: IRCCS Ospedale San Raffaele
Collaborators: Centro Cardiologico Monzino|University Hospital Padova|Fondazione Policlinico Universitario Agostino Gemelli IRCCS|Azienda Policlinico Umberto I|Azienda Ospedaliero Universitaria Maggiore della Carita|IRCCS Azienda Ospedaliero-Universitaria di Bologna|San Camillo Hospital, Rome|Clinica San Martino|University Of Perugia|Maria Cecilia Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1360
Study Design: Observational Model: |Time Perspective: p
Start Date: 1999-01
Completion Date: 2024-06

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 PFO closure yields a 59% relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals.

However, the follow-up duration in these studies averaged around 4 years, while only two studies report a median follow-up beyond 10 years. Considering the relative youth of the patients undergoing this procedure (average age being under 50 years across all studies), we can reasonably anticipate a substantial post-PFO closure lifespan for these individuals. Consequently, it is imperative to gather more extensive long-term follow-up data among PFO closure recipients The PROLONG (PFO tRanscatether Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter, national registry including men and women undergoing transcatheter PFO closure, with the aim of assessing the long-term (\>10 years) efficacy and safety of this procedure.

Primary Outcome Measures: Number of Participants with ischemic stroke, transient ischemic attack or systemic embolism (SE) post device implant (Primary Effectiveness Outcome), The primary effectiveness outcome is the composite incidence of stroke, transient ischemic attack (TIA), and systemic embolism (SE) post-PFO closure., Duration of follow-up (minimum of 10 years)|Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint), Device- or procedure- related serious adverse events post device implant, Duration of follow-up (minimum of 10 years)
Secondary Outcome Measures: Number of Participants with recurrent ischemic stroke, Incidence of ischemic stroke post-PFO closure., Time Frame: Duration of follow-up (minimum of 10 years)|Number of Participants withrecurrent transient ischemic attack (TIA), Incidence of transient ischemic attack (TIA) post-PFO closure., Time Frame: Duration of follow-up (minimum of 10 years)|Number of Participants with with recurrent systemic embolism (SE), Incidence of systemic embolism (SE) post-PFO closure., Time Frame: Duration of follow-up (minimum of 10 years)|Rate of Procedural Success, The rate of successful PFO closure as determined by the absence of severe residual shunt or any procedure- or device-related serious adverse event (SAE), Time Frame: Duration of follow-up (minimum of 10 years)|Incidence of Clinically Significant New Atrial Arrhythmia, The occurrence of new-onset atrial fibrillation (AF) or atrial flutter (AFL) following PFO-closure, Time Frame: Duration of follow-up (minimum of 10 years)|Rate of All-cause mortality, The overall mortality rate of patients post-PFO closure, including both cardiac and non-cardiac causes, documented during follow-up., Time Frame: Duration of follow-up (minimum of 10 years)|Rate of residual shunt, Characterization of presence and severity of a residual shunt post-PFO closure, as detected by follow-up echocardiographic assessments., Time Frame: Duration of follow-up (minimum of 10 years)|Incidence of Device-Related and procedure-related Complications, The rate of complications related to the PFO closure device, such as device embolization, erosion, or thrombosis, documented during follow-up., Time Frame: Duration of follow-up (minimum of 10 years)|Incidence of bleeding events, The rate of bleeding events according to the Bleeding Academic Research Consortium (BARC) criteria, Time Frame: Duration of follow-up (minimum of 10 years)|Incidence of migraine symptoms, The presence and severity of migraine symptoms will be documented, Time Frame: Duration of follow-up (minimum of 10 years)