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Evaluation of effectiveness and safety of the pulsed field ablation system in the treatment of paroxysmal atrial fibrillation

Evaluation of effectiveness and safety of three-dimensional cardiac electrophysiological mapping system, pulsed-field ablation device, magnetoelectric positioning circular pulsed-field ablation catheter and magnetoelectric positioning pressure sensing pulsed-field ablation catheter in combination for the treatment of paroxysmal atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091941
Enrollment
Unknown
Registered
2024-11-06
Start date
2022-08-03
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Paroxysmal atrial fibrillation

Interventions

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 80 years old 2) Patients with symptomatic paroxysmal atrial fibrillation 3) Willing to participate in the clinical investigation, receive follow-up as required by the protocol and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) Patients with previous ablation of atrial fibrillation, atrial tachycardia or atypical atrial flutter 2) Preoperative atrial tachycardia (= 30 s), atypical atrial flutter 3) Implantation of pacemaker, valve or pulmonary vein stent 4) After cardiac surgery 5) Hemorrhagic stroke within 6 months 6) Transient ischemic attack or ischemic stroke within 1 month 7) History of myocardial infarction or percutaneous transluminal coronary angioplasty within 3 months 8) Hypertrophic cardiomyopathy 9) Rheumatic heart disease 10) Patients with moderate to severe aortic valve disease, moderate to severe mitral stenosis, and severe other valve disease 11) Mental disorder or history of mental illness and inability to cooperate autonomously 12) Left atrial anteroposterior diameter > 50 mm 13) Left ventricular ejection fraction < 40% 14) Left atrial thrombosis 15) Patients with diaphragmatic paralysis 16) Lactating, pregnant or planning or potential pregnant women 17) Expected lifetime <12 months 18) Patients participating in other interventional clinical investigations 19) Not suitable for inclusion in the clinical investigation in the judgment of the investigator

Design outcomes

Primary

MeasureTime frame
Late success rate at 12 months;Incidence of major adverse events;

Secondary

MeasureTime frame
Acute success rate;Incidence of adverse events;Incidence of serious adverse events;

Countries

China

Contacts

Public ContactZhou Shenghua

The Second Xiangya Hospital of Central South University

zhoushenghua_guo@163.com+86 137 0748 3674

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026