Health TrialsbyHealthPanel

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

ConditionsAF - Atrial FibrillationIntracranial Hemorrhage, Spontaneous
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)

Fully dependent (modified Rankin Scale [mRS] score > 4)

Uncontrolled hypertension (systolic blood pressure > 160 mmHg)

Presence of uncontrolled active bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Catheter Ablation

    Procedure/Surgery

    For patients in the catheter ablation group, low-dose anticoagulation for 1 month after pulsed field ablation is recommended. Suggested regimens include rivaroxaban 10-15 mg once daily, dabigatran 110 mg twice daily, or edoxaban 30 mg once daily. 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.

  • Usual Care

    Drug

    Patients received standard medical therapy without anticoagulation.

Treatment groups

646 Participants
are divided into 2 treatment groups
Group A: Usual care GroupActive comparator 1 intervention
Group B: Catheter Ablation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism

Time frame
48 months

Secondary outcomes

1

Stroke and Systemic Embolism

Time frame
48 months
2

Cardiovascular death

Time frame
48 months
3

Ischemic Stroke

Time frame
48 months
4

Intracranial Hemorrhage

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now