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

December 30, 2025 updated by: Chang sheng Ma, Beijing Anzhen Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

646

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Ronghui Yu, MD
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Beijing AnZhen Hospital, Capital Medical University
    • Fujian
      • Xiamen, Fujian, China
        • Xiamen Cadiovascular Hospital
        • Principal Investigator:
          • Yan Wang, MD
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
        • Principal Investigator:
          • Yue Li, MD
      • Harbin, Heilongjiang, China
        • The Second Affiliated Hospital of Harbin Medical University
        • Principal Investigator:
          • Bo Yu, MD
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Qian Tong, MD
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Zuyi Yuan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage
  3. Able to Access Intracerebral Hemorrhage Imaging Data
  4. ECG indicating the presence of atrial fibrillation
  5. CHA₂DS₂-VA Score ≥ 2
  6. Willing to undergo randomization and able to complete follow-up as required

Exclusion Criteria:

  1. Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)
  2. Fully dependent (modified Rankin Scale [mRS] score > 4)
  3. Uncontrolled hypertension (systolic blood pressure > 160 mmHg)
  4. Presence of uncontrolled active bleeding
  5. Presence of active infection requiring antibiotic treatment
  6. End-stage renal failure or receiving dialysis treatment
  7. Presence of liver failure
  8. Untreated coronary artery disease with indication for revascularization
  9. Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography
  10. Expected life expectancy < 1 year (e.g., advanced malignant tumors, etc.)
  11. Pregnant, lactating, or women planning to become pregnant
  12. Presence of psychological or psychiatric disorders that prevent understanding or cooperation with the study
  13. Other conditions deemed unsuitable for participation in the study by the investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care Group
Drug: Usual Care
The use of antithrombotic therapy is at the discretion of the treating physician.
Experimental: Catheter Ablation Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism
Time Frame: 48 months
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: 48 months
48 months
Stroke and Systemic Embolism
Time Frame: 48 months
48 months
Ischemic Stroke
Time Frame: 48 months
48 months
Intracerebral Hemorrhage
Time Frame: 48 months
48 months
ISTH Major Bleeding
Time Frame: 48 months
48 months
Change in quality of life assessed by the Atrial Fibrillation Effect on QualiTy of life (AFEQT) questionnaire
Time Frame: 48 months
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.
48 months
Change in health-related quality of life assessed by the EQ-5D-5L questionnaire
Time Frame: 48 months
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.
48 months
Change in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
Time Frame: 48 months
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.
48 months
Change in cognitive function assessed by the Mini-Mental State Examination (MMSE)
Time Frame: 48 months
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.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2025246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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