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Clinical Trial of Pulsed Field Ablation Therapy Apparatus

Clinical Trial of Pulsed Field Ablation Therapy Apparatus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051894
Enrollment
Unknown
Registered
2021-10-09
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

atrial fibrillation

Interventions

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18-75 years; 2. A clear diagnosis of patients with paroxysmal atrial fibrillation; 3. The subjects voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Cardiac function NYHA class III-IV, ventricular ejection fraction (LVEF) <= 40%; 2. With unsuccessful or recurrent radiofrequency ablation in the past; 3. Acute or severe systemic infection, significantly abnormal liver and kidney function, uncontrolled hyperthyroidism or malignant tumor and end-stage disease; 4. Preoperative determination of the presence of multiple types of tachyarrhythmias; 5. Combined with severe organic cardiovascular disease; 6. Stroke and other cerebrovascular diseases and thromboembolic diseases within the past 3 months; 7. Those who have obvious bleeding tendency or suffer from blood system diseases and cannot tolerate anticoagulant drugs; 8. Mental disorder or a history of mental illness and unable to cooperate voluntarily, patients with a history of epilepsy; 9. Pregnant and lactating patients and those planning to become pregnant within one year; 10. Those with allergies; 11. Those who have participated in clinical trials of any drug and/or medical device within 1 month before enrollment; 12. The researcher believes that there are any other factors that are not suitable for inclusion or that affect the participation of subjects in the study.

Design outcomes

Primary

MeasureTime frame
Immediate success rate;ECG;

Countries

China

Contacts

Public ContactLu Chengzhi

Tianjin Medical University

5020200072@nankai.edu.cn+86 13512967656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026