Patent Foramen OvalePFO-ElderlyNCT04780022
Patent Foramen Ovale Closure in Older Patients
An observational study of Patent Foramen Ovale and Ischemic Stroke, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial summary
Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism. Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major cardiac outcomes, as well as survival rates and death origin. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Patent Foramen Ovale, Ischemic Stroke, Older People
- What is being tested?
- Clinical events at last follow-up
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to 1 Dec 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure.
Who may be able to join
- Patients older than 60 years who have experienced a previous paradoxical embolism (stroke, transient ischaemic attack or peripheral embolism) of unknown origin and underwent transcatheter PFO closure.
Who cannot join
- PFO closure indication other than paradoxical embolism (example: platypnea orthodeoxia syndrome).
- Surgical PFO closure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patent Foramen Ovale Closure in Older Patients: A Collaborative Multicenter Retrospective Study
- Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism.
- Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major cardiac outcomes, as well as survival rates and death origin.
- Seek for predictors of neurological event recurrence after the procedure.
Read the detailed description
In patients with cryptogenic stroke, up to 4 randomized trials and subsequent meta-analyses have recently shown a significant reduction in recurrent ischemic stroke events following percutaneous closure of patent foramen ovale (PFO) . All randomized trials but one excluded patients older than 60 years, and a mean patient age of about 50 years was reported in the single randomized trial including older patients. Thus, whereas PFO closure has been established as the new gold-standard therapy in young patients with cryptogenic stroke and PFO, there are no definite recommendations on the management of patients older than 60 years. Some studies have shown that older patients with cryptogenic stroke exhibit a much higher prevalence of PFO (compared with patients with stroke of known cause), similar to that in younger populations, but scarce data exist on acute and mid-term clinical outcomes of older patients undergoing PFO closure.
The investigators have recently reported the results of study comparing the long-term clinical outcomes of patients older (vs. younger) than 60 years in our centre. A total of 475 consecutive patients (90 older than 60 years) were included, and the main results can be summarized as follows: 1) older patients with cryptogenic embolism and PFO exhibited a higher burden of cardiovascular risk factors; 2) PFO closure was safe in older patients, with no differences in periprocedural complications compared with younger patients; 3) at long-term (median of 8 years) follow-up post-PFO closure, the global mortality rate was higher among older patients, but differences were driven by noncardiovascular mortality (mainly cancer), and 4) the rate of recurrent stroke/TIA was low (much lower than that predicted by the RoPE score), but there was a tendency toward a higher incidence of recurrent stroke/TIA among older patients, which appeared to be partially related to cardiovascular risk factor burden (no differences in recurrent ischemic event rate were observed after adjustment for baseline differences in cardiovascular risk factors between groups). The main limitation of this study was the relatively low number of patients older than 60 years, precluding an appropriate evaluation of the factors associated with poorer clinical outcomes in this population. Thus, the investigators are planning to confirm prior findings in a collaborative project including a much larger cohort of patients. Also, the results of this retrospective study would provide the rationale for a CIHR submission on a randomized trial targeting this group of patients.
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Older People
- Being tested
- Clinical events at last follow-up
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical events at last follow-upOther
Clinical events (stroke, transient ischemic attack, peripheral embolism, deep venous thrombosis, atrial fibrillation, myocardial infarction, bleeding episode, death) at last follow-up
| Study group | Role | What they receive |
|---|---|---|
| Older patients with cryptogenic embolism and PFO closure | Data (clinical events at last follow-up) on patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure will be collected. Receives: Other: Clinical events at last follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stroke
Measured: Through study completion, an average of 1 year
Rate of transient ischemic attack
Measured: Through study completion, an average of 1 year
Rate of peripheral embolism
Measured: Through study completion, an average of 1 year
Rate of deep venous thrombosis
Measured: Through study completion, an average of 1 year
Rate of atrial fibrillation
Measured: Through study completion, an average of 1 year
Rate of myocardial infarction
Measured: Through study completion, an average of 1 year
Rate of bleeding
Measured: Through study completion, an average of 1 year
Rate of death
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto General Hospital, Montreal Heart Institute, Ottawa Heart Institute, St. Boniface Hospital, Hospital Clinico de Madrid, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780022
- Sponsor's protocol ID
- PFO-Elderly
- Acronym
- PFO-Elderly
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sondergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjostrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L; Gore REDUCE Clinical Study Investigators. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med. 2017 Sep 14;377(11):1033-1042. doi: 10.1056/NEJMoa1707404.
PubMed 28902580Mas 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 29544871Wintzer-Wehekind J, Alperi A, Houde C, Cote JM, Del Val D, Cote M, Rodes-Cabau J. Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism. Rev Esp Cardiol (Engl Ed). 2020 Mar;73(3):219-224. doi: 10.1016/j.rec.2019.07.003. Epub 2019 Oct 1. English, Spanish.
PubMed 31585849Kent DM, Ruthazer R, Weimar C, Mas JL, Serena J, Homma S, Di Angelantonio E, Di Tullio MR, Lutz JS, Elkind MS, Griffith J, Jaigobin C, Mattle HP, Michel P, Mono ML, Nedeltchev K, Papetti F, Thaler DE. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013 Aug 13;81(7):619-25. doi: 10.1212/WNL.0b013e3182a08d59. Epub 2013 Jul 17.
PubMed 23864310
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patent Foramen Ovale Closure in Older Patients: A Collaborative Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT04780022
- Acronym / sponsor ID
- PFO-Elderly / PFO-Elderly
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Older People
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Collaborators
- Toronto General Hospital, Montreal Heart Institute, Ottawa Heart Institute, St. Boniface Hospital, Hospital Clinico de Madrid, Hospital Clinic of Barcelona
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Mar 2021 (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.
- Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism.
- Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major cardiac outcomes, as well as survival rates and death origin.
- Seek for predictors of neurological event recurrence after the procedure.
Detailed description
In patients with cryptogenic stroke, up to 4 randomized trials and subsequent meta-analyses have recently shown a significant reduction in recurrent ischemic stroke events following percutaneous closure of patent foramen ovale (PFO) . All randomized trials but one excluded patients older than 60 years, and a mean patient age of about 50 years was reported in the single randomized trial including older patients. Thus, whereas PFO closure has been established as the new gold-standard therapy in young patients with cryptogenic stroke and PFO, there are no definite recommendations on the management of patients older than 60 years. Some studies have shown that older patients with cryptogenic stroke exhibit a much higher prevalence of PFO (compared with patients with stroke of known cause), similar to that in younger populations, but scarce data exist on acute and mid-term clinical outcomes of older patients undergoing PFO closure.
The investigators have recently reported the results of study comparing the long-term clinical outcomes of patients older (vs. younger) than 60 years in our centre. A total of 475 consecutive patients (90 older than 60 years) were included, and the main results can be summarized as follows: 1) older patients with cryptogenic embolism and PFO exhibited a higher burden of cardiovascular risk factors; 2) PFO closure was safe in older patients, with no differences in periprocedural complications compared with younger patients; 3) at long-term (median of 8 years) follow-up post-PFO closure, the global mortality rate was higher among older patients, but differences were driven by noncardiovascular mortality (mainly cancer), and 4) the rate of recurrent stroke/TIA was low (much lower than that predicted by the RoPE score), but there was a tendency toward a higher incidence of recurrent stroke/TIA among older patients, which appeared to be partially related to cardiovascular risk factor burden (no differences in recurrent ischemic event rate were observed after adjustment for baseline differences in cardiovascular risk factors between groups). The main limitation of this study was the relatively low number of patients older than 60 years, precluding an appropriate evaluation of the factors associated with poorer clinical outcomes in this population. Thus, the investigators are planning to confirm prior findings in a collaborative project including a much larger cohort of patients. Also, the results of this retrospective study would provide the rationale for a CIHR submission on a randomized trial targeting this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older patients with cryptogenic embolism and PFO closure | – | Other: Clinical events at last follow-upData (clinical events at last follow-up) on patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure will be collected. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure.
Key inclusion criteria (1 listed)
- Patients older than 60 years who have experienced a previous paradoxical embolism (stroke, transient ischaemic attack or peripheral embolism) of unknown origin and underwent transcatheter PFO closure.
Key exclusion criteria (2 listed)
- PFO closure indication other than paradoxical embolism (example: platypnea orthodeoxia syndrome).
- Surgical PFO closure.
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 |
|---|---|---|
| Clinical events at last follow-upClinical events (stroke, transient ischemic attack, peripheral embolism, deep venous thrombosis, atrial fibrillation, myocardial infarction, bleeding episode, death) at last follow-up | Other | Older patients with cryptogenic embolism and PFO closure |
Primary outcome
Rate of stroke
Time frame: Through study completion, an average of 1 year
Rate of transient ischemic attack
Time frame: Through study completion, an average of 1 year
Rate of peripheral embolism
Time frame: Through study completion, an average of 1 year
Rate of deep venous thrombosis
Time frame: Through study completion, an average of 1 year
Rate of atrial fibrillation
Time frame: Through study completion, an average of 1 year
Rate of myocardial infarction
Time frame: Through study completion, an average of 1 year
Rate of bleeding
Time frame: Through study completion, an average of 1 year
Rate of death
Time frame: Through study completion, an average of 1 year
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 2 Mar 2022.
- Background: PubMed 28902580Sondergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjostrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L; Gore REDUCE Clinical Study Investigators. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med. 2017 Sep 14;377(11):1033-1042. doi: 10.1056/NEJMoa1707404.
- 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 31585849Wintzer-Wehekind J, Alperi A, Houde C, Cote JM, Del Val D, Cote M, Rodes-Cabau J. Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism. Rev Esp Cardiol (Engl Ed). 2020 Mar;73(3):219-224. doi: 10.1016/j.rec.2019.07.003. Epub 2019 Oct 1. English, Spanish.
- Background: PubMed 23864310Kent DM, Ruthazer R, Weimar C, Mas JL, Serena J, Homma S, Di Angelantonio E, Di Tullio MR, Lutz JS, Elkind MS, Griffith J, Jaigobin C, Mattle HP, Michel P, Mono ML, Nedeltchev K, Papetti F, Thaler DE. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013 Aug 13;81(7):619-25. doi: 10.1212/WNL.0b013e3182a08d59. Epub 2013 Jul 17.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale and Ischemic Stroke, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site 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 1 inclusion and 2 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Rate of stroke (time frame: Through study completion, an average of 1 year). The study lists 8 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 NCT04780022, which also lists 6 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 2 Mar 2022.