Atrial Fibrillation Clinical Trial
Official title:
Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion: a Randomized Control Trial
The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. AF patients over 18 years old 2. Patients had undergone left atrial appendage occlusion with WATCHMAN device and confirmed no significant peri-device leak or DRT at the 45-day CT 3. Patients have a history of ischemic thromboembolic events or have CHA2DS2-VASc score =3 Exclusion Criteria: 1. Patients with an indication of long-term antiplatelet therapy other than LAAO at the time of enrollment (eg, ACS, Intracranial vascular stenosis=75%) 2. Absolute contraindications to OAC 3. Absolute contraindications to anti-platelet therapy 4. Contraindications to MR or unwilling to receiving MR 5. Patients with clinical thromboembolicor major bleeding events within 45 days after LAA occlusion |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University | Jiangsu Taizhou People's Hospital, Second Affiliated Hospital of Nantong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of silent cerebral embolism (SCE) detected by MRI | New SCE at any MRI during the follow-up | 45 days to 12 months | |
Secondary | More than two new SCE detected by MRI | More than two new SCE at any MRI during the follow-up, describing the number, location and the size. | 45 days to 12 months | |
Secondary | Cognition function detected by MMSE test | Cognition score detected by MMSE test | 45 days to 12 months | |
Secondary | MoCA test | Cognition score detected by MoCA test | 45 days to 12 months | |
Secondary | Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events | Clinical thromboembolic including Ischemic stroke, Peripheral thromboembolic event, et al. Major bleeding including intracrania bleeding, gastrointestina bleeding et al. | 45 days to 12 months |
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