Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centro Cardiologico Monzino | OTHER |
| University Hospital Padova | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
| Azienda Policlinico Umberto I |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Closure | PFO closure with septal occluder device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septal Occluder Device | Device | Transcatheter PFO closure with any commercially available septal occluder device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with recurrent ischemic stroke | Incidence of ischemic stroke post-PFO closure. | Time Frame: Duration of follow-up (minimum of 10 years) |
| Number of Participants withrecurrent transient ischemic attack (TIA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30358849 | Background | 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. | |
| 30045912 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D055989 | Septal Occluder Device |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
| OTHER |
| Azienda Ospedaliero Universitaria Maggiore della Carita | OTHER |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
| San Camillo Hospital, Rome | OTHER |
| Clinica San Martino | UNKNOWN |
| University Of Perugia | OTHER |
| Maria Cecilia Hospital | OTHER |
Not provided
Not provided
Not provided
Incidence of transient ischemic attack (TIA) post-PFO closure.
| Time Frame: Duration of follow-up (minimum of 10 years) |
| Number of Participants with with recurrent systemic embolism (SE) | Incidence of systemic embolism (SE) post-PFO closure. | Time Frame: Duration of follow-up (minimum of 10 years) |
| Rate of Procedural Success | 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) | Time Frame: Duration of follow-up (minimum of 10 years) |
| Incidence of Clinically Significant New Atrial Arrhythmia | The occurrence of new-onset atrial fibrillation (AF) or atrial flutter (AFL) following PFO-closure | Time Frame: Duration of follow-up (minimum of 10 years) |
| Rate of All-cause mortality | The overall mortality rate of patients post-PFO closure, including both cardiac and non-cardiac causes, documented during follow-up. | Time Frame: Duration of follow-up (minimum of 10 years) |
| Rate of residual shunt | Characterization of presence and severity of a residual shunt post-PFO closure, as detected by follow-up echocardiographic assessments. | Time Frame: Duration of follow-up (minimum of 10 years) |
| Incidence of Device-Related and procedure-related Complications | The rate of complications related to the PFO closure device, such as device embolization, erosion, or thrombosis, documented during follow-up. | Time Frame: Duration of follow-up (minimum of 10 years) |
| Incidence of bleeding events | The rate of bleeding events according to the Bleeding Academic Research Consortium (BARC) criteria | Time Frame: Duration of follow-up (minimum of 10 years) |
| Incidence of migraine symptoms | The presence and severity of migraine symptoms will be documented | Time Frame: Duration of follow-up (minimum of 10 years) |
| 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. |
| 33724327 | 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. |
| 28902593 | 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. |
| 28902590 | 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. |
| 29544871 | 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. |
| 29229471 | 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. |
| 29590333 | 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. |
| 29122137 | 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. |
| 30678757 | 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. |
| 40562467 | Derived | 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. |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002545 | Brain Ischemia |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |