Ireland
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Recruiting Not applicable

SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)

NCT07316270 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-05-06
Last updated
2026-08-07

Condition(s) studied

AF - Atrial FibrillationIntracranial Hemorrhage, Spontaneous

Investigational drug(s) / intervention(s)

Catheter AblationUsual Care

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. Between 14 Days and 12 Months After Spontaneous Intracranial Hemorrhage (intraparenchymal or intraventricular hemorrhage, and subdural hematoma) 3. Able to Access Intracranial Hemorrhage Imaging Data 4. ECG indicating the presence of atrial fibrillation 5. CHA₂DS₂-VA Score ≥ 2 6. Willing to undergo randomization and able to complete follow-up as required Exclusion Criteria: 1. Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.) 2. Fully dependent (modified Rankin Scale \[mRS\] score \> 4) 3. Uncontrolled hypertension (systolic blood pressure \> 160 mmHg) 4. Presence of uncontrolled active bleeding 5. Presence of active infection requiring antibiotic treatment 6. End-stage renal failure or receiving dialysis treatment 7. Presence of liver failure 8. Untreated coronary artery disease with indication for revascularization 9. Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography 10. Expected life expectancy \< 1 year (e.g., advanced malignant tumors, etc.) 11. Pregnant, lactating, or women planning to become pregnant 12. Presence of psychological or psychiatric disorders that prevent understanding or cooperation with the study 13. Other conditions deemed unsuitable for participation in the study by the investigators

Primary outcome measure(s)

  • Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism — 48 months

Trial sites (7)

FacilityCityRegionStatus
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
Official registry record

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