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Prospective, multicenter, single-group target clinical trials evaluating the safety and efficacy of steep-pulse ablation instruments and single-use electrical pulse ablation catheters for the treatment of paroxysmal atrial fibrillation

Prospective, multicenter, single-group target clinical trials evaluating the safety and efficacy of steep-pulse ablation instruments and single-use electrical pulse ablation catheters for the treatment of paroxysmal atrial fibrillation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064903
Enrollment
Unknown
Registered
2022-10-21
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Zhongshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old and <= 75 years old; 2. Paroxysmal atrial fibrillation diagnosed by electrocardiogram or dynamic electrocardiogram; 3. Catheter ablation is planned; 4. Be able to understand the purpose of the research, show sufficient compliance with the research protocol, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Previously received radiofrequency ablation or other left atrial surgery; 2. Patients with cardiac function class (NYHA) III-IV; 3. Left ventricular ejection fraction (LVEF) 50 mm; 6. Patients with implanted cardiac pacemakers and defibrillators; 7. Patients with acute or severe systemic infection before operation; 8. Patients with stroke and other cerebrovascular diseases within 3 months before enrollment; 9. Patients with obvious bleeding tendency who cannot accept antiplatelet aggregation and/or anticoagulant therapy; 10. Patients with known dementia or mental illness; 11. Severe structural heart disease, including moderate-severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic heart disease, etc.; 12. Pregnant or breastfeeding women, or those who have a family plan within the next year; 13. Combined with other serious diseases before operation, or life expectancy less than 1 year; 14. Are participating in any other drug or medical device clinical trials, or may participate in any other drug or medical device clinical trials after being enrolled in this clinical trial; 15. The investigator judges that there are other conditions that are not suitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Long-term success rate;

Secondary

MeasureTime frame
Immediate success rate after operation;Incidence of atrial tachyarrhythmias 1 month, 3 months, 6 months, and 12 months postoperatively;EQ-5D scale scores for 6 months and 12 months postoperatively;

Countries

China

Contacts

Public ContactJunbo Ge

Hangzhou Ruidi Biotechnology Ltd.

ge.junbo@zs-hospital.sh.cn+86 13901977506

Outcome results

None listed

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