Catheter ablation for AF after spontaneous intracranial hemorrhage: SAFER-AF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SAFER-AF is a multicenter, open-label trial that randomizes adults with AF and a recent spontaneous intracranial hemorrhage to catheter ablation or usual care. The ablation approach uses pulsed field ablation (PFA) followed by a short course of low-dose direct oral anticoagulants. Participants will be followed for at least two years to assess a composite of death, stroke, and systemic embolism. The aim is to define a safer, individualized strategy balancing stroke prevention with bleeding risk. The study enrolls 646 participants across several Chinese centers and compares long-term net clinical benefit between the two strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Between 14 Days and 12 Months After Spontaneous Intracranial Hemorrhage (intraparenchymal or intraventricular hemorrhage, and subdural hematoma)
3. Able to Access Intracranial Hemorrhage Imaging Data
4. ECG indicating the presence of atrial fibrillation
5. CHA₂DS₂-VA Score ≥ 2
6. Willing to undergo randomization and able to complete follow-up as required

Exclusion Criteria:

1. Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)
2. Fully dependent (modified Rankin Scale \[mRS\] score \> 4)
3. Uncontrolled hypertension (systolic blood pressure \> 160 mmHg)
4. Presence of uncontrolled active bleeding
5. Presence of active infection requiring antibiotic treatment
6. End-stage renal failure or receiving dialysis treatment
7. Presence of liver failure
8. Untreated coronary artery disease with indication for revascularization
9. Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography
10. Expected life expectancy \< 1 year (e.g., advanced malignant tumors, etc.)
11. Pregnant, lactating, or women planning to become pregnant
12. Presence of psychological or psychiatric disorders that prevent understanding or cooperation with the study
13. Other conditions deemed unsuitable for participation in the study by the investigators

Where it's running

• Beijing Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Xiamen Cadiovascular Hospital
  Xiamen, Fujian, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting
• The First Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Not yet recruiting
• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Not yet recruiting
• The First Hospital of Jilin University
  Changchun, Jilin, China Not yet recruiting

Study contacts

• Principal investigator: Yan Wang — Xiamen Cardiovascular Hospital, Xiamen University
• Study coordinator: Liu He
• Email: theliu@139.com
• Phone: 13810720787

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Two Pulse Field Ablation Systems for Atrial Fibrillation

  This trial tests whether two different pulse field ablation systems perform similarly in persistent symptomatic AF patients, with a heart monitor implanted to track rhythm for up to 36 months.

  Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT07883629

• Abbreviated antithrombotic therapy after PCI in AF and MI

  This trial tests whether DOAC-only therapy works as well as DOAC plus clopidogrel after PCI in people with atrial fibrillation and a recent heart attack.

  Recruiting Chonnam National University Hospital · Gwangju, Gwangju · NCT07583784

• AI-guided robotic minimally invasive neurosurgery for intracerebral hemorrhage (RAINBOW-ICH)

  This trial will test whether AI-assisted, robotic-guided minimally invasive surgery helps adults with spontaneous intracerebral hemorrhage (including basal ganglia, intraventricular, and brainstem types) recover better than conventional care.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07205263

• Combining Pulmonary Vein Isolation with Renal Denervation for Atrial Fibrillation and Hypertension

  This study is testing if combining two treatments, Pulmonary Vein Isolation and Renal Denervation, can help people with Atrial Fibrillation and high blood pressure feel better and have better results than using just one treatment alone.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT05841615

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.