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

RECRUITINGN/ASponsored by Beijing Anzhen Hospital
Actively Recruiting
PhaseN/A
SponsorBeijing Anzhen Hospital
Started2026-05-06
Est. completion2030-01
Eligibility
Age18 Years+
Healthy vol.Accepted

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 intracerebral hemorrhage.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Age ≥ 18 years
2. Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage
3. Able to Access Intracerebral 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

Conditions3

AF - Atrial FibrillationHeart DiseaseICH - Intracerebral Hemorrhage

Interventions1

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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