AF - Atrial FibrillationNCT07316270
SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
A study testing Catheter Ablation in people with AF - Atrial Fibrillation and Intracranial Hemorrhage, Spontaneous, run by Beijing Anzhen Hospital at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AF - Atrial Fibrillation, Intracranial Hemorrhage, Spontaneous
- What is being tested?
- Catheter Ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 646 participants
- Where
- 7 sitesChina
- Study dates
- 6 May 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Liu HE, MD, +86 13810720787, theliu@139.com
Caihua Sang, MD, +86 010-81992281, sch9613070@sina.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin
Qian Tong, +86-0431-81879801, tongqian@jlu.edu.cn
Qian Tong, MD
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Yue Li, +86 13945057313, ly99ly@vip.163.com
Yue Li, MD
- Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Bo Yu, +86-0451-86605084, yubodr@163.coms
Bo Yu, MD
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Ronghui Yu, +86 13901080383, ronghuiyu@vip.sina.com
Ronghui Yu, MD
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Zuyi Yuan, +86-029-85323473, yue.wu@xjtu.edu.cn
Zuyi Yuan, MD
- Recruiting
Xiamen Cadiovascular Hospital
Xiamen, Fujian
Yan Wang, +86-0592-968120, wy@medmail.com.cn
Yan Wang, MD
About this study
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.
Read the 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 intracranial hemorrhage have AF. Previous randomized trials indicate that restarting anticoagulation may prevent ischemic stroke, but increase risk of recurrent intracranial hemorrhage. 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 intracranial hemorrhage, 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 intracranial hemorrhage.
- Being tested
- Catheter Ablation, Usual Care
- Medical subject headings
- Atrial Fibrillation, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or 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 CareDrug
Patients received standard medical therapy without anticoagulation.
| Study group | Role | What they receive |
|---|---|---|
| Usual care Group | Active comparator | Not described Receives: Drug: Usual Care |
| Catheter Ablation Group | Experimental | Not described Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism
Measured: 48 months
Secondary outcomes (9)
Stroke and Systemic Embolism
Measured: 48 months
Cardiovascular death
Measured: 48 months
Ischemic Stroke
Measured: 48 months
Intracranial Hemorrhage
Measured: 48 months
ISTH Major Bleeding
Measured: 48 months
Clinically relevant non-major bleeding
Measured: 48 months
Change in health-related quality of life assessed by the EQ-5D-5L questionnaire
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.
Measured: 48 months
Change in cognitive function assessed by the Mini-Mental State Examination (MMSE)
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.
Measured: 48 months
modified Rankin Scale score
The modified Rankin Scale (mRS) is a widely used tool for assessing functional disability and dependence in patients with stroke or other neurological disorders. Scores range from 0 to 6, with 0 indicating no symptoms, 5 indicating severe disability requiring constant care, and 6 indicating death. A higher score represents a poorer functional outcome.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start6 May 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AF - Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 646 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Principal investigator, Xiamen Cardiovascular Hospital, Xiamen UniversityCaihua Sang, Principal investigator, Beijing Anzhen HospitalChangsheng Ma, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316270
- Sponsor's protocol ID
- KS2025246
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
- ClinicalTrials.gov ID
- NCT07316270
- Acronym / sponsor ID
- KS2025246
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 646 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 intracranial hemorrhage have AF. Previous randomized trials indicate that restarting anticoagulation may prevent ischemic stroke, but increase risk of recurrent intracranial hemorrhage. 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 intracranial hemorrhage, 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 intracranial hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care Group | Active comparator | Drug: Usual Care |
| Catheter Ablation Group | Experimental | Procedure: Catheter Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter AblationFor 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. | Procedure or surgery | Catheter Ablation Group |
| Usual CarePatients received standard medical therapy without anticoagulation. | Drug | Usual care Group |
Primary outcome
Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism
Time frame: 48 months
9 secondary outcomes
Stroke and Systemic Embolism
Time frame: 48 months
Cardiovascular death
Time frame: 48 months
Ischemic Stroke
Time frame: 48 months
Intracranial Hemorrhage
Time frame: 48 months
ISTH Major Bleeding
Time frame: 48 months
Clinically relevant non-major bleeding
Time frame: 48 months
Change in health-related quality of life assessed by the EQ-5D-5L questionnaire
Time frame: 48 months
Change in cognitive function assessed by the Mini-Mental State Examination (MMSE)
Time frame: 48 months
modified Rankin Scale score
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for AF - Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Wang principal investigator
Xiamen Cardiovascular Hospital, Xiamen University
Caihua Sang principal investigator
Beijing Anzhen Hospital
Changsheng Ma principal investigator
Beijing Anzhen Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Ablation in people with AF - Atrial Fibrillation and Intracranial Hemorrhage, Spontaneous, run by Beijing Anzhen Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu He (13810720787, theliu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.