SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
Recruiting · NCT07316270 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Anzhen Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Catheter AblationUsual Care
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
7 locations listed.
- The First Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- Beijing Anzhen Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Xiamen Cadiovascular Hospital - Xiamen, Fujian, China
- The First Affiliated Hospital of Harbin Medical University - Harbin, Heilongjiang, China
- 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