NCT07316270Recruiting
SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 646 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 6 May 2026
- Primary completion date
- Jan 2030
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07316270
What you commit to
- Study type: Interventional
- Planned participants: 646
- From 6 May 2026 to the primary completion date, Jan 2030
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- End-stage renal failure or receiving dialysis treatment
Other illness
- Uncontrolled hypertension (systolic blood pressure \> 160 mmHg)
- Presence of uncontrolled active bleeding
- Presence of active infection requiring antibiotic treatment
- Presence of liver failure
- Untreated coronary artery disease with indication for revascularization
- Expected life expectancy \< 1 year (e.g., advanced malignant tumors, etc.)
- 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
Other
- Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)
- Fully dependent (modified Rankin Scale \[mRS\] score \> 4)
- Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography
- Pregnant, lactating, or women planning to become pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Not yet recruiting |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Xiamen Cadiovascular Hospital Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.