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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
646
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.
The use of antithrombotic therapy is at the discretion of the treating physician.
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
Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism
Time frame: 48 months
Stroke and Systemic Embolism
Time frame: 48 months
Cardiovascular death
Time frame: 48 months
Ischemic Stroke
Time frame: 48 months
Intracerebral Hemorrhage
Time frame: 48 months
ISTH Major Bleeding
Time frame: 48 months
Change in quality of life assessed by the Atrial Fibrillation Effect on QualiTy of life (AFEQT) questionnaire
The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire is a disease-specific, patient-reported outcome measure assessing health-related quality of life in patients with atrial fibrillation. The overall AFEQT score ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame: 48 months
Change in health-related quality of life assessed by the EQ-5D-5L questionnaire
The EQ-5D-5L (EuroQol five-dimension, five-level) questionnaire is a standardized, generic measure of health-related quality of life. It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Health states are converted into a single index value using a country-specific value set, with higher index values indicating better health-related quality of life.
Time frame: 48 months
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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
Change in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a 30-point cognitive screening tool assessing multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: 48 months
Change in cognitive function assessed by the Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination is a 30-point questionnaire used to assess global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: 48 months