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Not yet recruitingNCT06413147Updated May 14, 2024

Long-term Procedural and Device Related Complications of PFO Closure

An observational study in Patent Foramen Ovale, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Xuanwu Hospital, Beijing · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study summary

We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.

02

Conditions studied

  • Patent Foramen Ovale

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03

In context

Foramen Ovale, Patent

138 studies on the registry are indexed under Foramen Ovale, Patent; 47 are open to participants now.

This study's planned enrollment of 100 is below the median of 233 across 60 observational studies indexed under Foramen Ovale, Patent.

Browse Foramen Ovale, Patent studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.

Browse Xuanwu Hospital, Beijing studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients who underwent PFO closure and willing to participate in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients who underwent PFO closure

Exclusion criteria

Exclusion Criteria:

  • Unable to complete or adhere to the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • DevicePFO closure

    Surgery of PFO closure

06

What researchers measure

Primary outcomes

  1. ischemic stroke, Hemorrhagic stroke or transient ischemic attack

    Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

Secondary outcomes

  1. atrial fibrillation

    Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

  2. Hemorrhage related to the use of antithrombotic drugs

    Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

  3. residual leaks

    Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

  4. death

    Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

  5. open-heart surgery

    Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

  6. Other severe events related to PFO closure

    Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2024; primary completion for May 2029, 60 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2024
First posted
May 14, 2024
StartEst.
May 30, 2024
Primary completionEst.
May 30, 2029
CompletionEst.
May 30, 2029
Last update
May 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06413147
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
yinchunlin (Xuanwu Hospital, Capital Medical University, Xuanwu Hospital, Beijing) — Principal investigator
First posted
May 14, 2024
Start date
May 30, 2024 (estimated)
Primary completion
May 30, 2029 (estimated)
Completion
May 30, 2029 (estimated)
Last update
May 14, 2024

Study contacts

Chunlin Yin
Contact
yinclmail@163.com
13552566227
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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