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A clinical trial to evaluate the safety and efficacy of steep pulse ablation system and disposable electric pulse ablation catheter in the treatment of atrial fibrillation

A clinical trial to evaluate the safety and efficacy of steep pulse ablation system and disposable electric pulse ablation catheter in the treatment of atrial fibrillation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061067
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

atrial fibrillation

Interventions

Sponsors

He'nan Provincial Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Patients with atrial fibrillation diagnosed by clinical symptoms and electrocardiogram; 3. Patients with atrial fibrillation who have taken class I or III antiarrhythmic drugs before operation and are scheduled to be treated by catheter ablation; 4. The subjects or their legal guardians can understand the purpose of the study, show sufficient compliance with the research scheme, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous radiofrequency ablation or other left atrial surgery; 2. Patients with cardiac function classification (NYHA) grade ?-?; 3. Left ventricular ejection fraction (LVEF) 50mm; 6. Patients with implanted stimulators such as pacemakers and defibrillators; 7. Acute or severe systemic infection before operation; 8. Stroke and other cerebrovascular diseases occurred within 3 months before enrollment; 9. Obvious bleeding tendency and unable to receive antiplatelet aggregation and/or anticoagulation therapy; 10. Known to have dementia or mental illness; 11. Severe organic heart disease including moderate to severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic heart disease, etc.; 12. Pregnant or lactating women or those who have a birth plan in the coming year; 13. Preoperative complication of other serious diseases or life expectancy of less than 1 year; 14. Is participating in any other drug or medical device clinical trial, or may participate in any other drug or medical device clinical trial after enrolling in this clinical trial; 15. The researchers judged that there were other conditions that were not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Immediate success rate after operation;

Secondary

MeasureTime frame
The success rate of treatment 12 months after operation;Incidence of postoperative atrial tachyarrhythmia;Ablation time;Postoperative EQ-5D scale score;

Countries

China

Contacts

Public ContactYiqiang Yuan

He'nan Provincial Chest Hospital

zzqyyuanyiqiang@126.com+86 13838125038

Outcome results

None listed

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