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

Recruiting now · Not applicable

Conditions studied: AF - Atrial Fibrillation, Intracranial Hemorrhage, Spontaneous

In brief

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 facts

Study ID

NCT07316270

Run by

Beijing Anzhen Hospital

People needed

646

Starts

2026-05-06

Expected to finish

2030-01-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Between 14 Days and 12 Months After Spontaneous Intracranial Hemorrhage (intraparenchymal or intraventricular hemorrhage, and subdural hematoma)
• Able to Access Intracranial Hemorrhage Imaging Data
• ECG indicating the presence of atrial fibrillation
• CHA₂DS₂-VA Score ≥ 2
• Willing to undergo randomization and able to complete follow-up as required

You may not qualify if…

• Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)
• Fully dependent (modified Rankin Scale [mRS] score > 4)
• Uncontrolled hypertension (systolic blood pressure > 160 mmHg)
• Presence of uncontrolled active bleeding
• Presence of active infection requiring antibiotic treatment
• End-stage renal failure or receiving dialysis treatment
• Presence of liver failure
• Untreated coronary artery disease with indication for revascularization
• Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography
• Expected life expectancy < 1 year (e.g., advanced malignant tumors, etc.)
• Pregnant, lactating, or women planning to become pregnant
• Presence of psychological or psychiatric disorders that prevent understanding or cooperation with the study
• Other conditions deemed unsuitable for participation in the study by the investigators

Where it is running

• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Xiamen Cadiovascular Hospital — Xiamen, Fujian, China (enrolling)
• 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
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China

Full record on ClinicalTrials.gov

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