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Safety and eFfectiveness of cathetER ablation for Atrial Fibrillation with intracerebral hemorrhage

Safety and eFfectiveness of cathetER ablation for Atrial Fibrillation with intracerebral hemorrhage

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129118
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-05-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation combined with cerebral hemorrhage

Interventions

Catheter ablation group:Pulsed field ablation (PFA) treatment
Conventional treatment group:Conventional treatment (anticoagulation, blood pressure control, etc., at physician's discretion)

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years; 2.Between 14 Days and 12 Months After Spontaneous Intracerebral Hemorrhage (sICH); 3.Able to Access Intracerebral Hemorrhage Imaging Data; 4.ECG indicating the presence of atrial fibrillation (AF); 5.CHA2DS2-VA Score >= 2 Points; 6.Willing to undergo randomization and able to complete follow-up as required;

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation (AF) secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.); 2. Inability to perform activities of daily living (modified Rankin Scale [mRS] score > 4); 3. Complicated with uncontrolled hypertension (systolic blood pressure > 160 mmHg); 4. Presence of conditions associated with a high risk of bleeding, including but not limited to uncontrolled active bleeding, platelet count <100 × 10^9/L, or known or suspected inherited or acquired bleeding or coagulation disorders; 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 (TTE) or transesophageal echocardiography (TEE); 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.

Design outcomes

Primary

MeasureTime frame
All-cause mortality, all-cause stroke (including ischemic and hemorrhagic stroke), and systemic embolism;

Secondary

MeasureTime frame
Cardiovascular mortality;Ischemic stroke;Intracerebral hemorrhage;ISTH major bleeding;Quality of life assessment (AFEQT, EQ-5D-5L);Cognitive function assessment (Montreal Cognitive Assessment MoCA, Mini-Mental State Examination MMSE);Modified Rankin Scale (mRS) score;

Countries

China

Contacts

Public ContactMa Changsheng

Beijing Anzhen Hospital, Capital Medical University

chshma@vip.sina.com+86 10 64426153

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026