Health TrialsbyHealthPanel

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

ConditionsAF - Atrial FibrillationICH - Intracerebral Hemorrhage
Trial statusNot yet recruiting
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 intracerebral hemorrhage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage

Able to Access Intracerebral 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

    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

    Drug

    The use of antithrombotic therapy is at the discretion of the treating physician.

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

Intracerebral 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

This trial is not recruiting at the moment. You can still explore other options: