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A clinical study on the safety and feasibility of the cardiac pulsed electromagnetic field ablation system in treating persistent atrial f

A clinical study on the safety and feasibility of the cardiac pulsed electromagnetic field ablation system in treating persistent atrial fibrillation concurrently during cardiac surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127049
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-06-23
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

None

Interventions

Experimental group:Simultaneous treatment of persistent atrial fibrillation during cardiac surgery

Sponsors

Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18 - 80 years old (inclusive of 18 and 80). Gender is not restricted. 2.Planning to undergo cardiac surgery (including valve replacement or repair surgery, coronary artery bypass surgery, etc.); 3.Combination of persistent atrial fibrillation (Definition of persistent atrial fibrillation: The atrial fibrillation episode cannot terminate on its own, lasts for more than 7 days, and can be terminated through intervention); 4.Being able to understand the purpose of this trial, voluntarily participating in this study and signing the informed consent form, and willing to complete the follow-up as per the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Previously underwent cardiac surgical maze procedure; 2. Long R-R interval; 3. Requires urgent cardiac surgery (such as cardiogenic shock); 4. Requires intra-aortic balloon counterpulsation or intravenous cardiac stimulants before surgery; 5. Left ventricular ejection fraction (LVEF) = 6 cm; 7. Cardiac function classification (NYHA) IV grade; 8. Has one or more pulmonary vein stents, or has an implanted cardiac cardioverter defibrillator, pacemaker or any other implanted electronic device; 9. Patients with acute systemic active infection who, according to the investigator's judgment, cannot undergo surgical treatment; 10. Anticoagulation contraindications and those with a history of abnormal blood clotting or bleeding or a significant bleeding tendency who cannot undergo surgery or are undergoing hemodialysis for renal failure patients; 11. Patients who have experienced acute myocardial infarction within 6 weeks; 12. Patients who have experienced stroke (except for lacunar infarction) or transient ischemic attack within 6 months; 13. Patients with obvious surgical contraindications or an expected survival period < 1 year; 14. Subjects who are pregnant or breastfeeding or who cannot be prevented from contraception during the trial and are female with reproductive planning issues; 15. Subjects who are currently participating in another clinical study that has not yet completed the main endpoint; 16. Other situations that the investigator deems inappropriate for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The incidence of major adverse events (MAE) related to the equipment or the surgery within one month after the operation;

Secondary

MeasureTime frame
The effective rate of treatment 6 months after the surgery;Incidence of adverse events and serious adverse events;The rate of anti-arrhythmic re-intervention 6 months after the surgery;

Countries

China

Contacts

Public ContactLiu Jian

Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)

jameslau1984@sina.com+86 20 8382 7812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026