Patent Foramen Ovale Closure in Older Patients (PFO-Elderly)
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| ClinicalTrials.gov Identifier: NCT04780022 |
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Recruitment Status :
Completed
First Posted : March 3, 2021
Last Update Posted : March 2, 2022
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- 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Patent Foramen Ovale Ischemic Stroke Older People | Other: Clinical events at last follow-up |
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 Type : | Observational |
| Actual Enrollment : | 350 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Patent Foramen Ovale Closure in Older Patients: A Collaborative Multicenter Retrospective Study |
| Actual Study Start Date : | April 1, 2021 |
| Actual Primary Completion Date : | December 1, 2021 |
| Actual Study Completion Date : | December 1, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Clinical events at last follow-up
Clinical events (stroke, transient ischemic attack, peripheral embolism, deep venous thrombosis, atrial fibrillation, myocardial infarction, bleeding episode, death) at last follow-up |
- 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 ]
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- PFO closure indication other than paradoxical embolism (example: platypnea orthodeoxia syndrome).
- Surgical PFO closure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780022
| Canada | |
| CRIUCPQ | |
| Quebec, Canada, G1V 4G5 | |
| Responsible Party: | Josep Rodes-Cabau, Principal Investigator, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
| ClinicalTrials.gov Identifier: | NCT04780022 |
| Other Study ID Numbers: |
PFO-Elderly |
| First Posted: | March 3, 2021 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ischemic Stroke Foramen Ovale, Patent Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Heart Septal Defects, Atrial Heart Septal Defects Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases Congenital Abnormalities |