Patent Foramen OvaleNCT06413147
Long-term Procedural and Device Related Complications of PFO Closure
An observational study of Patent Foramen Ovale, run by Xuanwu Hospital, Beijing.
Trial summary
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Foramen Ovale
- What is being tested?
- PFO closure
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2024to 30 May 2029
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients who underwent PFO closure and willing to participate in this study.
Who may be able to join
- All patients who underwent PFO closure
Who cannot join
- Unable to complete or adhere to the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.
- Conditions
- Patent Foramen Ovale
- Being tested
- PFO closure
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO closureDevice
Surgery of PFO closure
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic stroke, Hemorrhagic stroke or transient ischemic attack
Measured: 1 month, 6 months, 1 year, 3 years, 5 years
Secondary outcomes (6)
atrial fibrillation
Measured: 1 month, 6 months, 1 year, 3 years, 5 years
Hemorrhage related to the use of antithrombotic drugs
Measured: 1 month, 6 months, 1 year, 3 years, 5 years
residual leaks
Measured: 1 month, 6 months, 1 year, 3 years, 5 years
death
Measured: 1 month, 6 months, 1 year, 3 years, 5 years
open-heart surgery
Measured: 1 month, 6 months, 1 year, 3 years, 5 years
Other severe events related to PFO closure
Measured: 1 month, 6 months, 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start30 May 2024 (estimated)
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yinchunlin, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413147
- Sponsor's protocol ID
- yinchunlin_PFO safety
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Procedural and Device Related Complications of PFO Closure
- ClinicalTrials.gov ID
- NCT06413147
- Acronym / sponsor ID
- yinchunlin_PFO safety
- Conditions
- Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 14 May 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.
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent PFO closure and willing to participate in this study.
Key inclusion criteria (1 listed)
- All patients who underwent PFO closure
Key exclusion criteria (1 listed)
- Unable to complete or adhere to the study
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 |
|---|---|---|
| PFO closureSurgery of PFO closure | Device | – |
Primary outcome
ischemic stroke, Hemorrhagic stroke or transient ischemic attack
Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
6 secondary outcomes
atrial fibrillation
Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
Hemorrhage related to the use of antithrombotic drugs
Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
residual leaks
Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
death
Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
open-heart surgery
Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
Other severe events related to PFO closure
Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
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 14 May 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale, run by Xuanwu Hospital, Beijing.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Chunlin Yin (13552566227, yinclmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic stroke, Hemorrhagic stroke or transient ischemic attack (time frame: 1 month, 6 months, 1 year, 3 years, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.