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

NCT07316270 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 646

Last updated 2026-01-05

No results posted yet for this study

Summary

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.

Conditions

  • AF - Atrial Fibrillation
  • ICH - Intracerebral Hemorrhage

Interventions

PROCEDURE

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.

DRUG

Usual Care

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

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316270 on ClinicalTrials.gov