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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
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

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Anzhen Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaNot yet recruiting
The Second Affiliated Hospital of Harbin Medical University
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HarbinChinaNot yet recruiting
The First Affiliated Hospital of Harbin Medical University
Coordinator of this site? Confirm its status
HarbinChinaNot yet recruiting
The First Affiliated Hospital of Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaNot yet recruiting
Xiamen Cadiovascular Hospital
Coordinator of this site? Confirm its status
XiamenChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi’anChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.