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

Completed

• Conditions: Patent Foramen Ovale; Stroke, Cryptogenic; Atrial Fibrillation New Onset; Transient Ischaemic Attack Due to Embolism
• Interventions: Device: Septal Occluder Device

• Registration Number: NCT06504121
• Lead Sponsor: IRCCS Ospedale San Raffaele

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 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.

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2013-12
• Study Completion: 2024-06
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1360

Inclusion Criteria

• 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 Criteria

• Age < 18 years;
• Previous surgical or transcatheter PFO closure;
• Patients without follow-up data available.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device Closure	Septal Occluder Device	PFO closure with septal occluder device.

Primary Outcome Measures

Name	Time	Method
Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint)	Duration of follow-up (minimum of 10 years)	Device- or procedure- related serious adverse events post device implant
Number of Participants with ischemic stroke, transient ischemic attack or systemic embolism (SE) post device implant (Primary Effectiveness Outcome)	Duration of follow-up (minimum of 10 years)	The primary effectiveness outcome is the composite incidence of stroke, transient ischemic attack (TIA), and systemic embolism (SE) post-PFO closure.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with recurrent ischemic stroke	Time Frame: Duration of follow-up (minimum of 10 years)	Incidence of ischemic stroke post-PFO closure.
Number of Participants with with recurrent systemic embolism (SE)	Time Frame: Duration of follow-up (minimum of 10 years)	Incidence of systemic embolism (SE) post-PFO closure.
Rate of Procedural Success	Time Frame: Duration of follow-up (minimum of 10 years)	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)
Rate of All-cause mortality	Time Frame: Duration of follow-up (minimum of 10 years)	The overall mortality rate of patients post-PFO closure, including both cardiac and non-cardiac causes, documented during follow-up.
Rate of residual shunt	Time Frame: Duration of follow-up (minimum of 10 years)	Characterization of presence and severity of a residual shunt post-PFO closure, as detected by follow-up echocardiographic assessments.
Incidence of Device-Related and procedure-related Complications	Time Frame: Duration of follow-up (minimum of 10 years)	The rate of complications related to the PFO closure device, such as device embolization, erosion, or thrombosis, documented during follow-up.
Number of Participants withrecurrent transient ischemic attack (TIA)	Time Frame: Duration of follow-up (minimum of 10 years)	Incidence of transient ischemic attack (TIA) post-PFO closure.
Incidence of bleeding events	Time Frame: Duration of follow-up (minimum of 10 years)	The rate of bleeding events according to the Bleeding Academic Research Consortium (BARC) criteria
Incidence of migraine symptoms	Time Frame: Duration of follow-up (minimum of 10 years)	The presence and severity of migraine symptoms will be documented
Incidence of Clinically Significant New Atrial Arrhythmia	Time Frame: Duration of follow-up (minimum of 10 years)	The occurrence of new-onset atrial fibrillation (AF) or atrial flutter (AFL) following PFO-closure