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

NCT06504121 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1360

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Septal Occluder Device

Transcatheter PFO closure with any commercially available septal occluder device

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    collaborator OTHER

  • University Hospital Padova

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • Azienda Policlinico Umberto I

    collaborator OTHER

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • San Camillo Hospital, Rome

    collaborator OTHER

  • Clinica San Martino

    collaborator UNKNOWN

  • University Of Perugia

    collaborator OTHER

  • Maria Cecilia Hospital

    collaborator OTHER

  • IRCCS Ospedale San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2013-12-31
Completion
2024-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504121 on ClinicalTrials.gov