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Pulsed electric field ablation versus catheter ablation for paroxysmal atrial fibrillation: a multicenter, randomized, non-blinded, controlled study

Pulsed electric field ablation versus catheter ablation for paroxysmal atrial fibrillation: a multicenter, randomized, non-blinded, controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065339
Enrollment
Unknown
Registered
2022-11-02
Start date
2022-11-05
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

Pulsed electric field ablation group:Pulsed electric field ablation

Sponsors

Zhengzhou Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Paroxysmal nonvalvular atrial fibrillation; 3. The patient has symptoms of atrial fibrillation and has the indications for RFCA for atrial fibrillation; 4. Preoperative transthoracic echocardiography showed that the maximum anterior and posterior diameter of the left atrium was less than or equal to 50mm; 5. Preoperative CTA examination of left atrial and pulmonary vein was completed to confirm the morphology of pulmonary vein; 6. Follow all evaluation and follow-up protocols.

Exclusion criteria

Exclusion criteria: 1. Congenital heart disease, valvular heart disease, unstable angina and acute myocardial infarction (MI) in three months, acute phase of myocarditis, cardiomyopathy, cor pulmonale, severe nerve system disease, severe disturbance of consciousness, serious neurological infections, etc.), mental illness, drug abuse, drug dependence, mental disorders can't cooperate), drug therapy and surgery can't control Thyroid dysfunction, autoimmune diseases, hematological diseases, malignant tumors, serious infections; 2. Concomitant with other chronic arrhythmias, such as atrioventricular block and sick sinus syndrome; At the same time with malignant ventricular arrhythmias, such as persistent ventricular tachycardia; 3. The stenosis of one or more major vessels (anterior descending artery, circumnavigating artery, right coronary artery) is more than or equal to 95% after coronary angiography or percutaneous coronary intervention for less than or equal to 3 months; 4. Patients with standardized cardiac function (NYHA New York Cardiac Function Class) IV, or left ventricular ejection fraction 3 times the upper limit of normal) or abnormal renal function (SCr > 3.5mg/dL or CCr < 30mL/min); 7. Patients with a history of cardiac surgery in the past 6 months; 8. There are contraindications of radiofrequency ablation (such as pregnancy, allergy to contrast media, etc.); 9. Those whose life expectancy is less than 12 months; Other patients who are not candidates for cardiac MRI (e.g. metal implants, etc.); 10. Participated in or is participating in other clinical studies within 3 months prior to the date on which informed consent was obtained.

Design outcomes

Primary

MeasureTime frame
Degree of fibrosis;

Countries

China

Contacts

Public ContactYujie Zhao

Zhengzhou Seventh People's Hospital

zyj@xxmu.edu.cn+86 18703677288

Outcome results

None listed

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