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

NCT ID: NCT06504121

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2024-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Device Closure

PFO closure with septal occluder device.

Septal Occluder Device

Intervention Type: DEVICE

Transcatheter PFO closure with any commercially available septal occluder device

Interventions

Septal Occluder Device

Transcatheter PFO closure with any commercially available septal occluder device

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: collaborator

University Hospital Padova

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: collaborator

Azienda Policlinico Umberto I

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: collaborator

San Camillo Hospital, Rome

OTHER

Sponsor Role: collaborator

Clinica San Martino

UNKNOWN

Sponsor Role: collaborator

University Of Perugia

OTHER

Sponsor Role: collaborator

Maria Cecilia Hospital

OTHER

Sponsor Role: collaborator

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Cosmo Godino

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 30358849 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30045912 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33724327 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28902593 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28902590 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29544871 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29229471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29590333 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29122137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30678757 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40562467 (View on PubMed)

Other Identifiers

09031943

Identifier Type: -

Identifier Source: org_study_id