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

NCT07316270 | Recruiting DMC

• 1 other identifier: KS2025246
• Study Type: interventional
• Target: 646
• Locations: 1 country
• Sites: 7

Brief 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 intracranial hemorrhage.

Conditions

AF - Atrial Fibrillation; Intracranial Hemorrhage, Spontaneous

Outcome Measures

Primary Outcomes (1)

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

  48 months

Secondary Outcomes (9)

• Stroke and Systemic Embolism

  48 months

• Cardiovascular death

  48 months

• Ischemic Stroke

  48 months

• Intracranial Hemorrhage

  48 months

• ISTH Major Bleeding

  48 months

Study Arms (2)

Usual care Group

ACTIVE COMPARATOR

Drug: Usual Care

Catheter Ablation Group

EXPERIMENTAL

Procedure: Catheter Ablation

Interventions

Catheter Ablation PROCEDURE

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.

Catheter Ablation Group

Usual Care DRUG

Patients received standard medical therapy without anticoagulation.

Usual care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• CHA₂DS₂-VA Score ≥ 2
• Willing to undergo randomization and able to complete follow-up as required

You may not qualify if:

• 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
• Presence of active infection requiring antibiotic treatment
• End-stage renal failure or receiving dialysis treatment
• Presence of liver failure
• Untreated coronary artery disease with indication for revascularization
• Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography
• Expected life expectancy \< 1 year (e.g., advanced malignant tumors, etc.)
• Pregnant, lactating, or women planning to become pregnant
• Presence of psychological or psychiatric disorders that prevent understanding or cooperation with the study
• Other conditions deemed unsuitable for participation in the study by the investigators

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (7)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

NOT YET RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

Xiamen Cadiovascular Hospital

Xiamen, Fujian, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Intracranial Hemorrhages

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Yan Wang

  Xiamen Cardiovascular Hospital, Xiamen University

  PRINCIPAL INVESTIGATOR

• Caihua Sang

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Changsheng Ma

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu He

CONTACT

13810720787; theliu@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 5, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)