SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracerebral Hemorrhage (SAFER-AF)
Trial statusNot yet recruiting
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 intracerebral hemorrhage.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage
Able to Access Intracerebral 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 groupsLocations
7The First Affiliated Hospital of Anhui Medical University230022, HefeiAnhui, China
Beijing Anzhen Hospital, Capital Medical University100029, BeijingBeijing Municipality, China
Xiamen Cadiovascular Hospital XiamenFujian, China
The First Affiliated Hospital of Harbin Medical University150001, HarbinHeilongjiang, China
Sponsors and collaborators
Beijing Anzhen Hospital
Lead sponsor
Source ClinicalTrials.gov