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Evaluate pulse electric field ablation instrument, disposable pulse ablation pen, disposable pulse The safety of using ablation forceps for the simultaneous treatment of persistent atrial fibrillation during cardiac surgery Prospective, multicenter, single-arm clinical trials for efficacy

Evaluate pulse electric field ablation instrument, disposable pulse ablation pen, disposable pulse The safety of using ablation forceps for the simultaneous treatment of persistent atrial fibrillation during cardiac surgery Prospective, multicenter, single-arm clinical trials for efficacy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117469
Enrollment
Unknown
Registered
2026-01-23
Start date
2026-01-23
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

persistent atrial fibrillation

Interventions

treatment group:During cardiac surgery, experimental instruments are used to perform concomitant ablation for atrial fibrillation

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80, with no gender preference 2. Planned cardiac surgery (including valve replacement or repair surgery, coronary artery bypass surgery, etc.) 3. Persistent atrial fibrillation (AF) (AF duration =7 days) 4. Agree to participate in this study and voluntarily sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Previously underwent cardiac surgical maze procedure 2. Requiring emergency cardiac surgery (such as cardiogenic shock) 3. Intra-aortic balloon counterpulsation or intravenous cardiotonic agents are required before surgery 4. Left ventricular ejection fraction (LVEF) =6 cm 6. Cardiac functional classification (NYHA) class IV 7. Equipped with one or multiple pulmonary vein stents, or implanted with an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic devices 8. Patients with systemic active infection who, according to the researchers' judgment, are unable to undergo surgical treatment 9. Renal failure patients with obvious bleeding tendency who cannot undergo surgery or are undergoing hemodialysis 10. Patients who have experienced acute myocardial infarction within 6 weeks five 11. Patients who have experienced a stroke (excluding lacunar infarction) or transient ischemic attack within the past 6 months 12. Patients with obvious surgical contraindications or an expected survival period of less than 1 year 13. Women who are pregnant or breastfeeding, or who have family planning during the study period 14. Patients who have participated in other drug or medical device clinical trials within 3 months 15. Patients whom researchers consider unsuitable for participation in this clinical trial

Design outcomes

Primary

MeasureTime frame
Success rate of treatment at 6 months post-surgery;

Secondary

MeasureTime frame
Effective treatment rate at 6 months after surgery;Antiarrhythmic reintervention rate at 6 months after surgery;Device performance evaluation;

Countries

China

Contacts

Public ContactGuo Huiming

Guangdong Provincial People's Hospital

525536652@qq.com+86 20 8382 7812

Outcome results

None listed

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