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The effectiveness and safety evaluation of ablation index guided 50W radiofrequency ablation in patients with paroxysmal atrial fibrillation: a prospective, multi-center, randomized controlled trial from China

The effectiveness and safety evaluation of ablation index guided 50W radiofrequency ablation in patients with paroxysmal atrial fibrillation: a prospective, multi-center, randomized controlled trial from China

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056663
Enrollment
Unknown
Registered
2022-02-10
Start date
2022-03-07
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Atrial Fibrillation

Interventions

Test group:AI guided 50W ablation
Control group:AI guided 30-35W ablation

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old, and = 75 years; 2. Symptomatic paroxysmal atrial fibrillation, the duration of atrial fibrillation is less than 7 days; 3. At least one antiarrhythmic drug fails or cannot be tolerated (including Class I or III antiarrhythmic drugs, or ß Receptor blockers, calcium channel blockers); Or the patient is willing to accept catheter ablation as the first-line treatment; 4. There is at least one atrial fibrillation attack in the 12 months before enrollment, and there are ECG records that can clearly diagnose atrial fibrillation. The recording methods are unlimited, including ECG, 24h Holter, ECG monitoring records, remote ECG monitoring, ECG screening records, and portable ECG monitoring equipment; 5. Preoperative withdrawal of antiarrhythmic drugs for at least 5 half-lives; 6. The patient is willing to accept radiofrequency ablation treatment, and willing to accept relevant preoperative examination and postoperative follow-up and examination; 7. The patient voluntarily signs the informed consent form approved by the ethics committee.

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation is secondary to electrolyte disorders, thyroid diseases or other reversible non-cardiac diseases; 2. Initial atrial fibrillation; 3. Have received surgery/ablation or catheter ablation for atrial fibrillation in the past; 4. Received percutaneous coronary intervention within 3 months (90 days) before admission; 5. Coronary artery bypass grafting was performed within 6 months (180 days) before admission; 6. Myocardial infarction or frequent unstable angina pectoris occurred within 3 months (90 days) before enrollment; 7. Thrombocytopenia (PLT 45 mm (TTE, parasternal long axis angle of view); 9. Left atrial (left atrial appendage) thrombus (TEE or MSCT examination); 10. Those who cannot tolerate TEE examination or contraindication of TEE examination; 11. Serious organic heart disease, including obstructive hypertrophic cardiomyopathy, atrial myxoma, myocardial amyloidosis, restrictive cardiomyopathy, constrictive pericarditis, uncontrolled heart failure (LVEF5mm; 14. Serious respiratory diseases, including acute attack of chronic obstructive pulmonary disease, severe pulmonary heart disease, severe pulmonary hypertension (pulmonary systolic pressure>50mmHg), acute pulmonary embolism, respiratory failure, etc; 15. Stroke/TIA history in the past 6 months; 16. Abnormal thyroid function (increased or decreased TSH); 17. Serious liver and kidney dysfunction (AST or ALT = 3 times the upper normal limit; Ccr<30 ml/min); 18. Active systemic infection or septicemia; 19. Abnormal vascular access; 20. Patients with active tumor; Or those who have not been diagnosed but are highly suspected of active tumor by imaging examination; 21. Severe chronic consumptive diseases and cachexia; 22. Women during pregnancy and/or lactation; 23. Patients with ICD or CRT/CRTD implanted in vivo; 24. Patients with previous or suspected heparin-induced thrombocytopenia; 25. The researcher believes that serious diseases or congenital abnormalities should be excluded from this study.

Design outcomes

Primary

MeasureTime frame
free of atrial fibrillation / flutter / atrial tachycardia rate in 1 year after catheter ablation;

Secondary

MeasureTime frame
pop rate;Incidence of perioperative complications;Stroke rate;mortality;Incidence of major cardiovascular events;Single cycle isolation rate;Left atrial catheter operation time;

Countries

China

Contacts

Public ContactCai Heng, Xia Yunlong

Tianjin Medical University General Hospital

Cardio_lhs@126.com+86 13821378394

Outcome results

None listed

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