Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT07300358
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 65 years.
* Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).
* Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).
* Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).
Exclusion Criteria:
* An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.
* Large territory cerebral infarction within 4 weeks prior to the planned procedure.
* Atherosclerotic stenosis (\>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.
* Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.
* Left ventricular ejection fraction (LVEF) \< 35%.
* Atrial fibrillation or atrial flutter.
* Left ventricular aneurysm or severe regional wall motion abnormality.
* Significant valvular stenosis or regurgitation, or history of valvular replacement or repair surgery.
* Pulmonary hypertension or a PFO constituting a special conduit (e.g., right-to-left shunt due to elevated right heart pressures).
* Other confirmed causes of right-to-left shunt, such as atrial septal defect (ASD) or pulmonary arteriovenous fistula.
* Complex PFO anatomy (e.g., multi-tunnel PFO) or PFO associated with an ASD requiring different closure strategy.
* Thrombus, mass, or vegetation identified at the intended implant site or along the potential delivery pathway.
* Acute myocardial infarction or unstable angina within 3 months prior to the procedure.
* Previous implantation of an inferior vena cava filter, PFO closure device, or ASD closure device.
* Any other condition deemed by the investigator to make the patient unsuitable for PFO device implantation.
* Concomitant cardiac anomalies requiring surgical correction.
* Uncontrolled systemic or local infection, or sepsis.
* Active infection requiring concurrent antibiotic therapy (Patients with transient conditions may be enrolled after completing antibiotic therapy and a subsequent 14-day washout period).
* Contraindication to antiplatelet or anticoagulant therapy (e.g., major bleeding within 3 months, known retinopathy, history of intracranial hemorrhage, or other significant intracranial pathology).
* Known hypersensitivity or allergy to tantalum or nickel.
* Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.
* Life expectancy less than 1 year due to malignancy or other comorbid disease.
* Current participation in another investigational drug or device clinical study that has not yet completed its primary endpoint.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07300358
Study Brief:
Protocol Section:
NCT07300358