Patent Foramen OvalePROLONGNCT06504121
PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
An observational study of Patent Foramen Ovale and Stroke, Cryptogenic, run by IRCCS Ospedale San Raffaele.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patent Foramen Ovale, Stroke, Cryptogenic, Transient Ischaemic Attack Due to Embolism
- What is being tested?
- Septal Occluder Device
- Type of treatment
- Medical device
- How many people
- 1,360 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age < 18 years;
- Previous surgical or transcatheter PFO closure;
- Patients without follow-up data available.
About this study
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.
Read the 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
- Being tested
- Septal Occluder Device
- Keywords
- Patent Foramen Ovale, Stroke, Cryptogenic, Stroke, Transient Ischemic Attack, Atrial Fibrillation, Interventional cardiology
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke, Stroke, Ischemic Attack, Transient, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septal Occluder DeviceDevice
Transcatheter PFO closure with any commercially available septal occluder device
| Study group | Role | What they receive |
|---|---|---|
| Device Closure | PFO closure with septal occluder device. Receives: Device: Septal Occluder Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Duration of follow-up (minimum of 10 years)
Secondary outcomes (10)
Number of Participants with recurrent ischemic stroke
Incidence of ischemic stroke post-PFO closure.
Measured: Time Frame: Duration of follow-up (minimum of 10 years)
Number of Participants withrecurrent transient ischemic attack (TIA)
Incidence of transient ischemic attack (TIA) post-PFO closure.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of migraine symptoms
The presence and severity of migraine symptoms will be documented
Measured: Time Frame: Duration of follow-up (minimum of 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study startJan 1999
- Primary completionDec 2013
- Study completionJun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Cardiologico Monzino, University Hospital Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Policlinico Umberto I, Azienda Ospedaliero Universitaria Maggiore della Carita, IRCCS Azienda Ospedaliero-Universitaria di Bologna, San Camillo Hospital, Rome, Clinica San Martino, University Of Perugia, Maria Cecilia Hospital
- Responsible party
- Principal investigator, Cosmo Godino, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504121
- Sponsor's protocol ID
- 09031943
- Acronym
- PROLONG
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30358849Kuijpers 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.
PubMed 30045912Mendelson 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.
PubMed 33724327Mas 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.
PubMed 28902593Saver 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.
PubMed 28902590Lee 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.
PubMed 29544871Vaduganathan 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.
PubMed 29229471Ahmad 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.
PubMed 29590333Mojadidi 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.
PubMed 29122137Wintzer-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.
PubMed 30678757Gaspardone 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.
PubMed 40562467
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
- ClinicalTrials.gov ID
- NCT06504121
- Acronym / sponsor ID
- PROLONG / 09031943
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- Centro Cardiologico Monzino, University Hospital Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Policlinico Umberto I, Azienda Ospedaliero Universitaria Maggiore della Carita, IRCCS Azienda Ospedaliero-Universitaria di Bologna, San Camillo Hospital, Rome, Clinica San Martino, University Of Perugia, Maria Cecilia Hospital
- Study start
- Jan 1999 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Closure | – | Device: Septal Occluder DevicePFO closure with septal occluder device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Age < 18 years;
- Previous surgical or transcatheter PFO closure;
- Patients without follow-up data available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Septal Occluder DeviceTranscatheter PFO closure with any commercially available septal occluder device | Device | Device Closure |
Primary outcome
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.
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
10 secondary outcomes
Number of Participants with recurrent ischemic stroke
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Number of Participants withrecurrent transient ischemic attack (TIA)
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Number of Participants with with recurrent systemic embolism (SE)
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Rate of Procedural Success
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of Clinically Significant New Atrial Arrhythmia
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Rate of All-cause mortality
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Rate of residual shunt
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of Device-Related and procedure-related Complications
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of bleeding events
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of migraine symptoms
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 30358849Pristipino 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.
- Background: PubMed 30045912Kuijpers 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.
- Background: PubMed 33724327Mendelson 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.
- Background: PubMed 28902593Mas 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.
- Background: PubMed 28902590Saver 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.
- Background: PubMed 29544871Lee 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.
- Background: PubMed 29229471Vaduganathan 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.
- Background: PubMed 29590333Ahmad 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.
- Background: PubMed 29122137Mojadidi 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.
- Background: PubMed 30678757Wintzer-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.
- Derived from this study: PubMed 40562467Gaspardone 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale and Stroke, Cryptogenic, run by IRCCS Ospedale San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06504121, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.