Patent Foramen OvaleSTOPNCT05907694
Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
A study testing Transcatheter PFO closure and Optimal medical treatment in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Josep Rodes-Cabau at 2 sites in Canada.
Trial summary
Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patent Foramen Ovale, Cryptogenic Stroke, Older Patients
- What is being tested?
- Transcatheter PFO closure and Optimal medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 714 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Jun 2024to 1 Oct 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Cryptogenic stroke
- Age >60 years
- Right-to-left shunt as evaluated by echocardiography (TEE).
Who cannot join
- -≤60 year-old
- Lacunar (small vessel) stroke.
- Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring).
- Need for chronic anticoagulation therapy.
- Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor).
- Presence of extracranial or intracranial atherosclerosis causing ≥50% luminal --stenosis in arteries supplying the area of ischemia.
Show all 30Show fewer
- Presence of complex atheroma plaques at the ascending aorta-aortic arch (≥4-mm-thick, ulcerated or containing mobile thrombi) as evaluated by TEE.
- Presence of intracardiac thrombus as evaluated by TEE.
- Uncontrolled hypertension (systemic pressure values >160/90 mmHg despite optimal medical treatment).
- History of myocardial infarction or coronary intervention. (percutaneous coronary intervention, coronary artery bypass graft).
- History of prior valve surgery or transcatheter valve repair.
- Presence of deep venous thrombosis at the time of index stroke as evaluated by Doppler ultrasonography.
- Left ventricular ejection fraction <50% as evaluated by TTE.
- Significant (moderate or severe) valvular disease as evaluated by echocardiography.
- History of congestive heart failure.
- Severe chronic kidney dysfunction defined an estimated glomerular filtration rate <30 ml/min/m2 or need for dialysis.
- Isolated ASD or ASD associated with PFO but with a hemodynamically significant left-to-right shunt requiring closure.
- Other specific cause of stroke identified (eg, arteritis, dissection, migraine/vasospasm, and drug abuse).
- Prior surgical or endovascular treatments of PFO or ASD.
- Rheumatic heart disease.
- Left atrial enlargement defined as a left atrial diameter >41 mm in men and ≥39 mm in women.
- Presence of high burden of premature atrial contractions (>500 per 24 hrs) as evaluated by continuous ECG monitoring.
- Follow-up impossible or expected poor compliance.
- Active cancer.
- Presence of an inferior vena cava filter.
- Severe pulmonary artery hypertension (systolic pulmonary pressure >60 mmHg).
- Functional dependency as measured by a modified Rankin Scale score >3 (unable to attend to own bodily needs without assistance and unable to walk unassisted).
- Any medical condition determining a life expectancy <2 years.
- Participation in another randomized study.
- Failure to provide signed informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 1 recruiting
- Active, not recruiting
IUCPQ-UL
Québec, Quebec, G1V 4G5
- Recruiting
IUCPQ
Québec, Quebec, G2E4G9
Mélanie Côté, 4186537270, melanie.cote@criucpq.ulaval.ca
About this study
Official title: Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial
Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.
Read the detailed description
Background and importance Consistent with studies performed in younger patient cohorts, older patients suffering a cryptogenic stroke exhibit a much higher prevalence of patent foramen ovale (PFO) compared to their stroke of known origin counterparts. Several studies have provided promising preliminary data regarding PFO closure in older patients with cryptogenic stroke, with very low stroke recurrence rates at mid- to long-term follow-up. Several randomized trials have shown the beneficial effects of PFO closure vs. medical treatment in patients younger than 60 years with cryptogenic stroke and PFO. Current observational data suggest similar or even more marked effects on stroke recurrence prevention of PFO closure in older patients and would support the design of a randomized trial to provide definite evidence in this field. Therefore, the objective of the present study is to evaluate the efficacy of transcatheter PFO closure for preventing recurrent ischemic stroke (nonlacunar) events in patients >60 years diagnosed with a cryptogenic stroke and PFO.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical Treatment, Recurrent Stroke
- Being tested
- Transcatheter PFO closure, Optimal medical treatment
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter PFO closureProcedure or surgery
Transcatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study.
Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.
Optimal medical treatmentDrug
Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.
| Study group | Role | What they receive |
|---|---|---|
| transcatheter PFO closure + optimal medical treatment | Experimental | Patients will undergoes transcatheter PFO closure (+ optimal medical treatment). Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient. Receives: Procedure: Transcatheter PFO closure; Drug: Optimal medical treatment |
| Optimal medical treatment | Experimental | Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient. Receives: Drug: Optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ischemic events
New ischemic non-lacunar stroke events
Measured: 12 months
Secondary outcomes (8)
Rate of stroke events
All new non-lacunar stroke events
Measured: 12 months
Rate of mortality
All cause mortality
Measured: 10 year follow-up
Rate of cardiovascular mortality
Cardiovascular death
Measured: 10 year follow-up
Incidence of cerebral hemorrhage
Cerebral bleeding
Measured: 10 year follow-up
Rate of new-onset atrial fibrillation
All new onset atrial fibrillation episodes
Measured: 10 year follow-up
Rate of bleeding
Major/life-threatening bleeding
Measured: 10 year follow-up
Health-related quality of life
Evaluated by the EQ-5D-5L questionnaire
Measured: 10 year follow-up
Neurocognitive assessment
Evaluated by the MoCA questionnaire
Measured: 10 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start18 Jun 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing transcatheter PFO closure + medical treatment vs. medical treatment alone.
- Masking
- None (open label)
- Enrolment
- 714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josep Rodes-Cabau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- IUCPQ Rodes-Cabau, MD, PhD, Principal investigator, Fondation IUCPQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907694
- Sponsor's protocol ID
- STOP
- Acronym
- STOP
- Status last verified
- Mar 2026
- First submitted
- 8 Jun 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
PubMed 30879893Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PubMed 35078371Zhao W, Wu J, Liu J, Wu Y, Ni J, Gu H, Tu J, Wang J, An Z, Ning X. Trends in the incidence of recurrent stroke at 5 years after the first-ever stroke in rural China: a population-based stroke surveillance from 1992 to 2017. Aging (Albany NY). 2019 Mar 19;11(6):1686-1694. doi: 10.18632/aging.101862.
PubMed 30888967Cho KK, Khanna S, Lo P, Cheng D, Roy D. Persistent pathology of the patent foramen ovale: a review of the literature. Med J Aust. 2021 Jul;215(2):89-93. doi: 10.5694/mja2.51141. Epub 2021 Jul 4.
PubMed 34218432Molnar AA, Abraham P, Merkely B, Nardai S. Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure. J Vis Exp. 2022 Feb 8;(180). doi: 10.3791/61240.
PubMed 35225286Ho SY, McCarthy KP, Rigby ML. Morphological features pertinent to interventional closure of patent oval foramen. J Interv Cardiol. 2003 Feb;16(1):33-8. doi: 10.1046/j.1540-8183.2003.08000.x.
PubMed 12664815Agarwal S, Bajaj NS, Kumbhani DJ, Tuzcu EM, Kapadia SR. Meta-analysis of transcatheter closure versus medical therapy for patent foramen ovale in prevention of recurrent neurological events after presumed paradoxical embolism. JACC Cardiovasc Interv. 2012 Jul;5(7):777-89. doi: 10.1016/j.jcin.2012.02.021.
PubMed 22814784Alsheikh-Ali AA, Thaler DE, Kent DM. Patent foramen ovale in cryptogenic stroke: incidental or pathogenic? Stroke. 2009 Jul;40(7):2349-55. doi: 10.1161/STROKEAHA.109.547828. Epub 2009 May 14.
PubMed 19443800Lechat P, Mas JL, Lascault G, Loron P, Theard M, Klimczac M, Drobinski G, Thomas D, Grosgogeat Y. Prevalence of patent foramen ovale in patients with stroke. N Engl J Med. 1988 May 5;318(18):1148-52. doi: 10.1056/NEJM198805053181802.
PubMed 3362165Handke M, Harloff A, Olschewski M, Hetzel A, Geibel A. Patent foramen ovale and cryptogenic stroke in older patients. N Engl J Med. 2007 Nov 29;357(22):2262-8. doi: 10.1056/NEJMoa071422.
PubMed 18046029Pristipino 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 30358849Chen JZ, Thijs VN. Atrial Fibrillation Following Patent Foramen Ovale Closure: Systematic Review and Meta-Analysis of Observational Studies and Clinical Trials. Stroke. 2021 May;52(5):1653-1661. doi: 10.1161/STROKEAHA.120.030293. Epub 2021 Feb 22.
PubMed 33611943Hakeem A, Cilingiroglu M, Katramados A, Boudoulas KD, Iliescu C, Gundogdu B, Marmagkiolis K. Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):1153-1160. doi: 10.1002/ccd.27487. Epub 2018 Jan 14.
PubMed 29332308Musto C, Cifarelli A, Dipasquale F, Chin D, Nazzaro MS, Stio RE, Pennacchi M, De Felice F. A Comparison Between Gore Cardioform and Amplatzer Septal Occluder for Percutaneous Closure of Patent Foramen Ovale Associated With Atrial Septal Aneurysm: Clinical and Echocardiographic Outcomes. J Invasive Cardiol. 2021 Nov;33(11):E857-E862. doi: 10.25270/jic/20.00655. Epub 2021 Oct 15.
PubMed 34653958
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial
- ClinicalTrials.gov ID
- NCT05907694
- Acronym / sponsor ID
- STOP / STOP
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical Treatment, Recurrent Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- Josep Rodes-CabauUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2037 (estimated)
- First posted
- 18 Jun 2023 (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 closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.
Detailed description
Background and importance Consistent with studies performed in younger patient cohorts, older patients suffering a cryptogenic stroke exhibit a much higher prevalence of patent foramen ovale (PFO) compared to their stroke of known origin counterparts. Several studies have provided promising preliminary data regarding PFO closure in older patients with cryptogenic stroke, with very low stroke recurrence rates at mid- to long-term follow-up. Several randomized trials have shown the beneficial effects of PFO closure vs. medical treatment in patients younger than 60 years with cryptogenic stroke and PFO. Current observational data suggest similar or even more marked effects on stroke recurrence prevention of PFO closure in older patients and would support the design of a randomized trial to provide definite evidence in this field. Therefore, the objective of the present study is to evaluate the efficacy of transcatheter PFO closure for preventing recurrent ischemic stroke (nonlacunar) events in patients >60 years diagnosed with a cryptogenic stroke and PFO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing transcatheter PFO closure + medical treatment vs. medical treatment alone.
| Arm | Type | Receives |
|---|---|---|
| transcatheter PFO closure + optimal medical treatment | Experimental | Procedure: Transcatheter PFO closure, Drug: Optimal medical treatmentPatients will undergoes transcatheter PFO closure (+ optimal medical treatment). Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient. |
| Optimal medical treatment | Experimental | Drug: Optimal medical treatmentPatients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cryptogenic stroke
- Age >60 years
- Right-to-left shunt as evaluated by echocardiography (TEE).
Key exclusion criteria (30 listed)
- -≤60 year-old
- Lacunar (small vessel) stroke.
- Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring).
- Need for chronic anticoagulation therapy.
- Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor).
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 |
|---|---|---|
| Transcatheter PFO closureTranscatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study. Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient. | Procedure or surgery | transcatheter PFO closure + optimal medical treatment |
| Optimal medical treatmentPatients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient. | Drug | Optimal medical treatment, transcatheter PFO closure + optimal medical treatment |
Primary outcome
Rate of ischemic events
Time frame: 12 months
New ischemic non-lacunar stroke events
8 secondary outcomes
Rate of stroke events
Time frame: 12 months
Rate of mortality
Time frame: 10 year follow-up
Rate of cardiovascular mortality
Time frame: 10 year follow-up
Incidence of cerebral hemorrhage
Time frame: 10 year follow-up
Rate of new-onset atrial fibrillation
Time frame: 10 year follow-up
Rate of bleeding
Time frame: 10 year follow-up
Health-related quality of life
Time frame: 10 year follow-up
Neurocognitive assessment
Time frame: 10 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 34024117Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Background: PubMed 30879893GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
- Background: PubMed 35078371Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
- Background: PubMed 30888967Zhao W, Wu J, Liu J, Wu Y, Ni J, Gu H, Tu J, Wang J, An Z, Ning X. Trends in the incidence of recurrent stroke at 5 years after the first-ever stroke in rural China: a population-based stroke surveillance from 1992 to 2017. Aging (Albany NY). 2019 Mar 19;11(6):1686-1694. doi: 10.18632/aging.101862.
- Background: PubMed 34218432Cho KK, Khanna S, Lo P, Cheng D, Roy D. Persistent pathology of the patent foramen ovale: a review of the literature. Med J Aust. 2021 Jul;215(2):89-93. doi: 10.5694/mja2.51141. Epub 2021 Jul 4.
- Background: PubMed 35225286Molnar AA, Abraham P, Merkely B, Nardai S. Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure. J Vis Exp. 2022 Feb 8;(180). doi: 10.3791/61240.
- Background: PubMed 12664815Ho SY, McCarthy KP, Rigby ML. Morphological features pertinent to interventional closure of patent oval foramen. J Interv Cardiol. 2003 Feb;16(1):33-8. doi: 10.1046/j.1540-8183.2003.08000.x.
- Background: PubMed 22814784Agarwal S, Bajaj NS, Kumbhani DJ, Tuzcu EM, Kapadia SR. Meta-analysis of transcatheter closure versus medical therapy for patent foramen ovale in prevention of recurrent neurological events after presumed paradoxical embolism. JACC Cardiovasc Interv. 2012 Jul;5(7):777-89. doi: 10.1016/j.jcin.2012.02.021.
- Background: PubMed 19443800Alsheikh-Ali AA, Thaler DE, Kent DM. Patent foramen ovale in cryptogenic stroke: incidental or pathogenic? Stroke. 2009 Jul;40(7):2349-55. doi: 10.1161/STROKEAHA.109.547828. Epub 2009 May 14.
- Background: PubMed 3362165Lechat P, Mas JL, Lascault G, Loron P, Theard M, Klimczac M, Drobinski G, Thomas D, Grosgogeat Y. Prevalence of patent foramen ovale in patients with stroke. N Engl J Med. 1988 May 5;318(18):1148-52. doi: 10.1056/NEJM198805053181802.
- Background: PubMed 18046029Handke M, Harloff A, Olschewski M, Hetzel A, Geibel A. Patent foramen ovale and cryptogenic stroke in older patients. N Engl J Med. 2007 Nov 29;357(22):2262-8. doi: 10.1056/NEJMoa071422.
- 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.
- Individual participant dataSharing planned: No
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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.
IUCPQ Rodes-Cabau, MD, PhD principal investigator
Fondation IUCPQ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter PFO closure and Optimal medical treatment in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Josep Rodes-Cabau at 2 sites in Canada.
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 3 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josep Rodes-Cabau, MD, PhD (4186568711, josep.rodes@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ischemic events (time frame: 12 months). 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 NCT05907694, which also lists 37 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 27 Mar 2026.