SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Catheter Ablation
- Usual Care
Treatment groups
646 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov