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NCT06504121Completed

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

Source: ClinicalTrials.gov · Last updated 16 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1360 (actual)
First submitted
4 Jul 2024
Start date
1 Jan 1999
Primary completion date
31 Dec 2013
Lead sponsor
IRCCS Ospedale San Raffaele
NCT number
NCT06504121

What you commit to

  • Study type: Observational
  • Participants enrolled: 1360
  • From 1 Jan 1999 to the primary completion date, 31 Dec 2013
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous surgical or transcatheter PFO closure;

Age

  • Age \< 18 years;

Other

  • Patients without follow-up data available.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.