SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracerebral Hemorrhage (SAFER-AF)

Capital Medical University

Status: Not yet enrolling

Conditions: AF - Atrial Fibrillation; ICH - Intracerebral Hemorrhage

Treatments: Drug: Usual Care; Procedure: Catheter Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07316270

KS2025246

Details and patient eligibility

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 intracerebral hemorrhage.

Full description

Atrial fibrillation (AF) increases the risk of stroke, heart failure, and mortality. Oral anticoagulation is the standard treatment for preventing thromboembolism, but it also raises the risk of bleeding. About 20-25% of patients with intracerebral hemorrhage (ICH) have AF. Previous randomized trials indicate that restarting anticoagulation may prevent ischemic stroke, but increase risk of recurrent ICH. Catheter ablation is the first-line rhythm control strategy that reduce thromboembolic risk by maintaining sinus rhythm and potentially reducing the need for long-term anticoagulation. Pulsed field ablation (PFA) uses electroporation to ablate the myocardium by electroporation with high tissue specificity and may shorten the required anticoagulation period.

The SAFER-AF trial is a prospective, multicenter, open-label randomized controlled trial enrolling 646 AF patients with previous spontaneous ICH, investigating whether catheter ablation provides superior long-term net clinical benefit compared with usual care. Participants will be randomized 1:1 to catheter ablation versus usual care, with a minimum follow-up of 2 years. Patients in catheter ablation group will undergo PFA, followed by low-dose direct oral anticoagulants for 1 month. The primary endpoint is the composite of all-cause mortality, all-cause stroke (ischemic or hemorrhagic), and systemic embolism. SAFER-AF aims to define a safer, individualized therapeutic pathway balancing ischemic protection and hemorrhagic risk, ultimately improving survival and long-term outcomes for AF patients with ICH.

Enrollment: 646 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage
3. Able to Access Intracerebral 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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646 participants in 2 patient groups

Usual care Group

Active Comparator group

Treatment:

Drug: Usual Care

Catheter Ablation Group

Experimental group

Treatment:

Procedure: Catheter Ablation