NCT06504121

PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,360 (actual)
• Sponsor: IRCCS Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 foramen ovale (PFO) closure between 1999 and 2013 at 12 Italian high-volume Centers. Patients will have at least 10 years of follow-up post-procedure. The primary objectives of the study are to evaluate the long-term clinical effectiveness of PFO closure by the incidence of left-sided embolic events and to evaluate safety by assessing serious device- or procedure-related adverse events. Secondary objectives include the incidence of new-onset atrial arrhythmias, the presence and severity of residual shunts, the incidence and severity of migraine symptoms, and bleeding events.

Conditions

• Patent Foramen Ovale
• Stroke, Cryptogenic
• Transient Ischaemic Attack Due to Embolism
• Atrial Fibrillation New Onset

Interventions

Type	Name	Description
DEVICE	Septal Occluder Device	Transcatheter PFO closure with any commercially available septal occluder device

Timeline

• Start date: 1999-01-01
• Primary completion: 2013-12-01
• Completion: 2024-06-01
• First posted: 2024-07-16
• Last updated: 2024-07-16