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

NCT06504121 | Completed

• 1 other identifier: 09031943
• Study Type: observational
• Target: 1,360
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

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

  The primary effectiveness outcome is the composite incidence of stroke, transient ischemic attack (TIA), and systemic embolism (SE) post-PFO closure.

  Duration of follow-up (minimum of 10 years)

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

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

  Duration of follow-up (minimum of 10 years)

Secondary Outcomes (10)

• Number of Participants with recurrent ischemic stroke

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

• Number of Participants withrecurrent transient ischemic attack (TIA)

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

• Number of Participants with with recurrent systemic embolism (SE)

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

• Rate of Procedural Success

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

• Incidence of Clinically Significant New Atrial Arrhythmia

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

Study Arms (1)

Device Closure

PFO closure with septal occluder device.

Device: Septal Occluder Device

Interventions

Septal Occluder Device DEVICE

Transcatheter PFO closure with any commercially available septal occluder device

Device Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (11)

• Pristipino C, Sievert H, D'Ascenzo F, Louis Mas J, Meier B, Scacciatella P, Hildick-Smith D, Gaita F, Toni D, Kyrle P, Thomson J, Derumeaux G, Onorato E, Sibbing D, Germonpre P, Berti S, Chessa M, Bedogni F, Dudek D, Hornung M, Zamorano J; Evidence Synthesis Team; Eapci Scientific Documents and Initiatives Committee; International Experts. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. Eur Heart J. 2019 Oct 7;40(38):3182-3195. doi: 10.1093/eurheartj/ehy649.

  PMID: 30358849 BACKGROUND

• Kuijpers T, Spencer FA, Siemieniuk RAC, Vandvik PO, Otto CM, Lytvyn L, Mir H, Jin AY, Manja V, Karthikeyan G, Hoendermis E, Martin J, Carballo S, O'Donnell M, Vartdal T, Baxter C, Patrick-Lake B, Scott J, Agoritsas T, Guyatt G. Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke? A clinical practice guideline. BMJ. 2018 Jul 25;362:k2515. doi: 10.1136/bmj.k2515. No abstract available.

  PMID: 30045912 BACKGROUND

• Mendelson SJ, Prabhakaran S. Diagnosis and Management of Transient Ischemic Attack and Acute Ischemic Stroke: A Review. JAMA. 2021 Mar 16;325(11):1088-1098. doi: 10.1001/jama.2020.26867.

  PMID: 33724327 BACKGROUND

• Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G; CLOSE Investigators. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017 Sep 14;377(11):1011-1021. doi: 10.1056/NEJMoa1705915.

  PMID: 28902593 BACKGROUND

• Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.

  PMID: 28902590 BACKGROUND

• Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.

  PMID: 29544871 BACKGROUND

• Vaduganathan M, Qamar A, Gupta A, Bajaj N, Golwala HB, Pandey A, Bhatt DL. Patent Foramen Ovale Closure for Secondary Prevention of Cryptogenic Stroke: Updated Meta-Analysis of Randomized Clinical Trials. Am J Med. 2018 May;131(5):575-577. doi: 10.1016/j.amjmed.2017.11.027. Epub 2017 Dec 8.

  PMID: 29229471 BACKGROUND

• Ahmad Y, Howard JP, Arnold A, Shin MS, Cook C, Petraco R, Demir O, Williams L, Iglesias JF, Sutaria N, Malik I, Davies J, Mayet J, Francis D, Sen S. Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials. Eur Heart J. 2018 May 7;39(18):1638-1649. doi: 10.1093/eurheartj/ehy121.

  PMID: 29590333 BACKGROUND

• Mojadidi MK, Elgendy AY, Elgendy IY, Mahmoud AN, Elbadawi A, Eshtehardi P, Patel NK, Wayangankar S, Tobis JM, Meier B. Transcatheter Patent Foramen Ovale Closure After Cryptogenic Stroke: An Updated Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2017 Nov 13;10(21):2228-2230. doi: 10.1016/j.jcin.2017.09.002. No abstract available.

  PMID: 29122137 BACKGROUND

• Wintzer-Wehekind J, Alperi A, Houde C, Cote JM, Asmarats L, Cote M, Rodes-Cabau J. Long-Term Follow-Up After Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism. J Am Coll Cardiol. 2019 Jan 29;73(3):278-287. doi: 10.1016/j.jacc.2018.10.061.

  PMID: 30678757 BACKGROUND

• Gaspardone C, Trabattoni D, d'Atri DO, Morosato M, Costa P, Fraccaro C, Donti A, Saia F, Toscano E, Scalise F, Cucco A, Patti G, Nerla R, Castriota F, Trani C, Improta R, Mancone M, Sardella G, Musto C, Paciaroni M, Morciano DA, Ricchetti G, Zaccaria L, Beneduce A, Barone G, Salerno A, Vella CS, Montorfano M, Pappone C, Colombo A, Maisano F, Burzotta F, Tarantini G, Margonato A, Gaspardone A, Godino C. 15-Year Outcomes of PFO Closure in Patients With Cryptogenic Embolism: Insights From the PROLONG Registry. JACC Cardiovasc Interv. 2025 Jun 23;18(12):1526-1537. doi: 10.1016/j.jcin.2025.04.041.

  PMID: 40562467 DERIVED

MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke; Stroke; Ischemic Attack, Transient; Atrial Fibrillation

Interventions

Septal Occluder Device

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Ischemia; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 16, 2024
• Study Start: January 1, 1999
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07