Clinical trial NCT06504121: PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
Official title: PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Foramen Ovale
Stroke, Cryptogenic
Transient Ischaemic Attack Due to Embolism
Atrial Fibrillation New Onset
Keywords: Patent Foramen Ovale
Stroke, Cryptogenic
Stroke
Transient Ischemic Attack
Atrial Fibrillation
Interventional cardiology
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
name: University Hospital Padova
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Azienda Policlinico Umberto I
name: Azienda Ospedaliero Universitaria Maggiore della Carita
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: San Camillo Hospital, Rome
name: Clinica San Martino
name: University Of Perugia
name: Maria Cecilia Hospital
First posted: 2024-07-16
Enrollment: 1360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The PROLONG registry will enroll a total of 1360 subjects who underwent transcatheter patent foramen ovale (PFO) closure between 1999 and 2013 at 12 high-volume Italian Centers.

Subjects range in age and gender and encompass individuals from both urban and rural areas, representing a comprehensive sample of patients typically seen in a real-world clinical setting.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with ischemic stroke, transient ischemic attack or systemic embolism (SE) post device implant (Primary Effectiveness Outcome)
timeFrame: Duration of follow-up (minimum of 10 years)
measure: Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint)
timeFrame: Duration of follow-up (minimum of 10 years)
Secondary outcomes:
measure: Number of Participants with recurrent ischemic stroke
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Number of Participants withrecurrent transient ischemic attack (TIA)
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Number of Participants with with recurrent systemic embolism (SE)
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Rate of Procedural Success
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Incidence of Clinically Significant New Atrial Arrhythmia
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Rate of All-cause mortality
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Rate of residual shunt
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Incidence of Device-Related and procedure-related Complications
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Incidence of bleeding events
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
measure: Incidence of migraine symptoms
timeFrame: Time Frame: Duration of follow-up (minimum of 10 years)
Other outcomes:
Locations:
Study officials:
References:
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