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SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
Sponsor: Beijing Anzhen Hospital
Summary
SAFER-AF is an investigator-initiated, multicenter, open-label, parallel-group trial comparing catheter ablation versus usual care in patients with atrial fibrillation and intracranial hemorrhage.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
646
Start Date
2026-05-06
Completion Date
2030-01
Last Updated
2026-08-07
Healthy Volunteers
No
Interventions
Catheter Ablation
For patients in the catheter ablation group, low-dose anticoagulation for 1 month after pulsed field ablation is recommended. Suggested regimens include rivaroxaban 10-15 mg once daily, dabigatran 110 mg twice daily, or edoxaban 30 mg once daily. For patients with paroxysmal atrial fibrillation (AF), an ablation strategy based on bilateral pulmonary vein isolation (PVI) is adopted. For patients with persistent AF, PVI plus ethanol infusion of the vein of Marshall and linear ablation (mitral isthmus, cavotricuspid isthmus, and left atrial roof) strategy is recommended. Other additional ablation strategies are determined by the operator.
Usual Care
Patients received standard medical therapy without anticoagulation.
Locations (7)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xiamen Cadiovascular Hospital
Xiamen, Fujian, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China