Cerebral Microembolization Associated With PFO Closure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorChina National Center for Cardiovascular Diseases
About this trial
This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
In this study, there are two groups of the patients who will undergo transcatheter closure. (1) PFO patients (n=600); (2) ASD patients (n=200). Before transcatheter closure, all patients will undergo brain DW-MRI. After the transcatheter closure, DW-MRI will be performed 24 hours and 4 weeks postoperatively. In addition, the presence or absence of in situ thrombus within the PFO will be determined in patients with PFO.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PFO occluder; ASD occluder
DeviceTranscatheter closure of atrial septal defect (ASD) and patent foramen ovale (PFO) All cases will be examined with DW-MRI preoperatively, and DW-MRI will be repeated 24 hours and 4 weeks after the transcatheter closure procedure.
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: PFO closure1 intervention
Group B: ASD closure1 intervention
Trial outcomes
Primary outcomes
1
De novo cerebral microembolization
cerebral microembolization with diffusion-weighted magnetic resonance imaging
Time frame
24 hours to 4 weeks after closure of PFO/ASDSponsors and contacts
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China National Center for Cardiovascular Diseases
Lead sponsor
Beijing Anzhen Hospital
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Tibet Autonomous Region People's Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Source ClinicalTrials.gov