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Completed

NCT Number: NCT06504121

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

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.

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Key information

Conditions

Patent Foramen Ovale Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation New Onset Brain Diseases Brain Ischemia Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Ischemic Attack, Transient Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Stroke, Cryptogenic Transient Ischaemic Attack Due to Embolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Septal Occluder Device

Device

Transcatheter PFO closure with any commercially available septal occluder device

Primary outcomes

  1. Number of Participants with ischemic stroke, transient ischemic attack or systemic embolism (SE) post device implant (Primary Effectiveness Outcome)

    Time frame: 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.

  2. Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint)

    Time frame: Duration of follow-up (minimum of 10 years)

    Device- or procedure- related serious adverse events post device implant

Secondary outcomes

  1. Number of Participants with recurrent ischemic stroke

    Time frame: Time Frame: Duration of follow-up (minimum of 10 years)

    Incidence of ischemic stroke post-PFO closure.

  2. Number of Participants withrecurrent transient ischemic attack (TIA)

    Time frame: Time Frame: Duration of follow-up (minimum of 10 years)

    Incidence of transient ischemic attack (TIA) post-PFO closure.

  3. Number of Participants with with recurrent systemic embolism (SE)

    Time frame: Time Frame: Duration of follow-up (minimum of 10 years)

    Incidence of systemic embolism (SE) post-PFO closure.

  4. Rate of Procedural Success

    Time frame: 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)

  5. Incidence of Clinically Significant New Atrial Arrhythmia

    Time frame: 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

  6. Rate of All-cause mortality

    Time frame: 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.

  7. Rate of residual shunt

    Time frame: 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.

  8. Incidence of Device-Related and procedure-related Complications

    Time frame: 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.

  9. Incidence of bleeding events

    Time frame: Time Frame: Duration of follow-up (minimum of 10 years)

    The rate of bleeding events according to the Bleeding Academic Research Consortium (BARC) criteria

  10. Incidence of migraine symptoms

    Time frame: Time Frame: Duration of follow-up (minimum of 10 years)

    The presence and severity of migraine symptoms will be documented

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Azienda Policlinico Umberto I
  • Centro Cardiologico Monzino
  • Clinica San Martino
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Maria Cecilia Hospital
  • San Camillo Hospital, Rome
  • University Hospital Padova
  • University Of Perugia

Registry information

Acronym: PROLONG

Important dates

Study start
1999
Primary completion
2013
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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