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COMParison of radiofrequency, cryoballoon, and pulsed feld Ablation on ceRebral Embolic events and cognitive outcomes in paroxysmal Atrial Fibrillation

COMParison of radiofrequency, cryoballoon, and pulsed feld Ablation on ceRebral Embolic events and cognitive outcomes in paroxysmal Atrial Fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115020
Enrollment
Unknown
Registered
2025-12-21
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Atrial fibrillation

Interventions

Radiofrequency ablation:The RFA procedure uses the CARTO magnetic-electrical combined mapping system (Biosense Webster, Inc.) or the Ensite three-dimensional electroanatomical mapping system (Saint Ju
Pulsed field ablation:After confirming the successful puncture through angiography, PFA connected the disposable cardiac pulsed electrical field ablation catheter (produced by Shenzhen Huite Medical C
Cryoballoon ablation:During the CBA procedure, patients remain supine and conscious. Puncture sites on the right internal jugular and bilateral femoral veins are disinfected with iodophor, and a steri

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) There is a clearly recorded AF attack waveform in 12-lead electrocardiogram or a single-lead electrocardiogram lasting for more than 30 seconds; (2) Age is 18 years or older; (3) Planned to undergo RFA, CBA or PFA surgery at this center; (4) Voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Known cognitive impairment (baseline MoCA score less than 26) or less than 6 years of compulsory education (2) Presence of magnetic resonance contraindications (claustrophobia, history of panic attacks, or presence of non-removable metal devices in the body) (3) Acute coronary syndrome, acute stroke, or having undergone cardiac surgery within 3 months (4) Previous multiple AF ablation history or pacemaker implantation history (5) Severe liver dysfunction and renal dysfunction (6) Any untreated or uncontrolled hyperthyroidism (7) Severe active infection (8) Complicated with severe heart valve disease (9) Pregnant or lactating (10) Had acute myocardial infarction within 3 months before enrollment (11) Left ventricular ejection fraction (LVEF) less than 35% (12) Presence of congenital heart disease, regardless of whether it has been corrected (13) Presence of other arrhythmias requiring ablation treatment (14) Left atrial thrombus (15) Left atrial diameter (LAD) greater than 55mm (long-axis view of the sternum in transthoracic echocardiography) (16) Participating in other clinical trial projects simultaneously (17) Medical staff participating in this study.

Design outcomes

Primary

MeasureTime frame
Silent cerebral embolism;Cognitive function;

Secondary

MeasureTime frame
Silent cerebral lesion;AF recurrence;Intracranial microbleeds;Overt stroke;Other complications after AF ablation;

Countries

China

Contacts

Public ContactQiming Liu

The Second Xiangya Hospital of Central South University

qimingliu@csu.edu.cn+86 138 7318 1753

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026