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New treatment option for Patent Foramen Ovale
Official title Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
ClinicalTrials.gov ID: NCT05907694
What this study is testing
What is Optimal medical treatment?
Optimal medical treatment is an investigational medicine, being studied as a potential treatment for patent foramen ovale.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cryptogenic stroke
- Age \>60 years
- Right-to-left shunt as evaluated by echocardiography (TEE).
You likely can't join if
- -≤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.
See the full eligibility criteria
- Cryptogenic stroke
- Age \>60 years
- Right-to-left shunt as evaluated by echocardiography (TEE).
- -≤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.
- 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 assigned by chance study.
- Failure to provide signed informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.