SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism — 48 months
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Not Yet Recruiting |
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| Xiamen Cadiovascular Hospital | Xiamen | Fujian | Recruiting |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| The First Hospital of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Not Yet Recruiting |
More Beijing Anzhen Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07316270 on ClinicalTrials.gov ↗ ← All trials in China