SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracerebral Hemorrhage (SAFER-AF)
NCT ID: NCT07316270
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
646 participants
INTERVENTIONAL
2026-01-31
2030-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Usual care Group
Usual Care
The use of antithrombotic therapy is at the discretion of the treating physician.
Catheter Ablation Group
Catheter Ablation
All patients undergo pulsed field ablation, followed by low-dose rivaroxaban for 1 month. For patients with paroxysmal atrial fibrillation (AF), an ablation strategy based on bilateral pulmonary vein isolation (PVI) is adopted. For patients with persistent AF, PVI plus ethanol infusion of the vein of Marshall and linear ablation (mitral isthmus, cavotricuspid isthmus, and left atrial roof) strategy is recommended. Other additional ablation strategies are determined by the operator. Anticoagulation therapy is discontinued after 1 month if no AF is detected during patient monitoring.
Interventions
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Catheter Ablation
All patients undergo pulsed field ablation, followed by low-dose rivaroxaban for 1 month. For patients with paroxysmal atrial fibrillation (AF), an ablation strategy based on bilateral pulmonary vein isolation (PVI) is adopted. For patients with persistent AF, PVI plus ethanol infusion of the vein of Marshall and linear ablation (mitral isthmus, cavotricuspid isthmus, and left atrial roof) strategy is recommended. Other additional ablation strategies are determined by the operator. Anticoagulation therapy is discontinued after 1 month if no AF is detected during patient monitoring.
Usual Care
The use of antithrombotic therapy is at the discretion of the treating physician.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Responsible Party
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Chang sheng Ma
Director of Cardiology Department
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KS2025246
Identifier Type: -
Identifier Source: org_study_id
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