PFO - Patent Foramen OvaleBioMetalNCT06203873
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
A study testing Biodegradable occluder and Metal occluder in people with PFO - Patent Foramen Ovale and Migraine, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites in China.
Trial summary
Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PFO - Patent Foramen Ovale, Migraine, Migraine Headache
- What is being tested?
- Biodegradable occluder and Metal occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Diagnosed migraine by ICHD-3
- History of migraine longer than 1 year, and symptoms severely disturbing daily life.
- TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt
- Willing to participant and agree to follow-ups
- Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.
Who cannot join
- Migraine caused by other reason
- Had TIA/stroke history
- With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
- With contraindication to PFO occlusion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Xiangbin Pan, MD, 86+88396666, panxiangbin@fuwaihospital.org
Xiangbin Pan, MD
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Xiangbin Pan, 088396666, panxiangbin@fuwaihospital.org
About this study
Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants.
Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\'s team, Professor Pan Xiangbin\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness.
To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.
- Conditions
- PFO - Patent Foramen Ovale, Migraine, Migraine Headache, Migraine Headache, With or Without Aura
- Being tested
- Biodegradable occluder, Metal occluder
- Medical subject headings
- Foramen Ovale, Patent, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable occluderDevice
Patients assigned in this group will receive PFO occlusion with a biodegradable occluder.
Metal occluderDevice
Patients assigned in this group will receive metal occluder for PFO occlusion
| Study group | Role | What they receive |
|---|---|---|
| Biodegradable Occluder Cohort | Experimental | Not described Receives: Device: Biodegradable occluder |
| Metal Occluder Cohort | Active comparator | Not described Receives: Device: Metal occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced days per month at 12 month's follow-up
In the 12th month of follow-up, the average reduction in migraine days per month
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PFO - Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203873
- Sponsor's protocol ID
- 2023-2229
- Acronym
- BioMetal
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li Z, Dong J, Dong J, Yan Y, Gao M, Fang F, Zhang F, Ouyang W, Wang S, Wang C, Pan X; BioMetal investigators. Comparison of biodegradable and metal occluders in patients with PFO and migraine: study design and rationale of BioMetal Trial. Trials. 2025 Aug 13;26(1):289. doi: 10.1186/s13063-025-09011-5.
PubMed 40804644
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
- ClinicalTrials.gov ID
- NCT06203873
- Acronym / sponsor ID
- BioMetal / 2023-2229
- Conditions
- PFO - Patent Foramen Ovale, Migraine, Migraine Headache, Migraine Headache, With or Without Aura
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 12 Jan 2024 (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.
Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants.
Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\'s team, Professor Pan Xiangbin\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness.
To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodegradable Occluder Cohort | Experimental | Device: Biodegradable occluder |
| Metal Occluder Cohort | Active comparator | Device: Metal occluder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65
- Diagnosed migraine by ICHD-3
- History of migraine longer than 1 year, and symptoms severely disturbing daily life.
- TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt
- Willing to participant and agree to follow-ups
Key exclusion criteria (4 listed)
- Migraine caused by other reason
- Had TIA/stroke history
- With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
- With contraindication to PFO occlusion
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 |
|---|---|---|
| Biodegradable occluderPatients assigned in this group will receive PFO occlusion with a biodegradable occluder. | Device | Biodegradable Occluder Cohort |
| Metal occluderPatients assigned in this group will receive metal occluder for PFO occlusion | Device | Metal Occluder Cohort |
Primary outcome
Reduced days per month at 12 month's follow-up
Time frame: 12 months
In the 12th month of follow-up, the average reduction in migraine days per month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 40804644Li Z, Dong J, Dong J, Yan Y, Gao M, Fang F, Zhang F, Ouyang W, Wang S, Wang C, Pan X; BioMetal investigators. Comparison of biodegradable and metal occluders in patients with PFO and migraine: study design and rationale of BioMetal Trial. Trials. 2025 Aug 13;26(1):289. doi: 10.1186/s13063-025-09011-5.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodegradable occluder and Metal occluder in people with PFO - Patent Foramen Ovale and Migraine, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites in China.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Pan, MD (8688396666, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced days per month at 12 month's follow-up (time frame: 12 months). 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 NCT06203873, which also lists 1 linked publication.
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 4 Dec 2025.