Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System (NCT07300358) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System
258 participantsStarted 2025-12-30
Plain-language summary
To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a biodegradable PFO occluder, which is different from the permanent metal devices already in use — can you explain what it would mean for my heart if the device dissolves over time, and whether that's considered safe based on what's known so far?
2Since this trial is listed as 'not yet recruiting,' how long do you think it might be before it opens, and is it worth waiting for it or should we be looking at currently available PFO closure options now?
3The trial is listed as Phase NA, which makes it harder for me to understand how much safety data already exists — can you help me understand what stage of testing this device is really at and what that means for the unknowns I'd be taking on?
4The main thing this trial is measuring is whether the device successfully closes the PFO — does that mean longer-term outcomes like stroke prevention aren't being directly studied yet, and how does that affect how we'd think about my options?
5Given that I have a history of stroke or TIA, would you recommend I consider a standard approved PFO closure procedure first rather than waiting for this trial, or do you think there's a good reason to hold out for this biodegradable option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success rate of effective occlusion
Timeframe: at 12 months post-implantation
Trial details
NCT IDNCT07300358
SponsorShanghai Lingsi Medical Technology Co., Ltd.