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Repeat ablation with "4E" strategy for patients with Recurrence of Atrial Fibrillation after ablation: a prospective observational study (4E-RAF)

Repeat ablation with "4E" strategy for patients with Recurrence of Atrial Fibrillation after ablation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093674
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-10
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Atrial fibrillation

Interventions

case series:None

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 30 and <= 90 years old 2. Subjects with atrial fibrillation and had undergone at least one time of ablation and has been confirmed to recur outside 3 months after the last ablation; 3. Subjects who agreed to participate in this study and were willing to sign an informed consent; 4. Being able to complete the study according to the research protocols, including ablation prodedure and follow-up.

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation induced by reversible causes, such as untreated hyperthyroidism; 2. Severe organic heart disease such as severe mitral stenosis or reflux, severe aortic stenosis or reflux, hypertrophic obstructive cardiomyopathy, dilated cardiomyopathy, and restrictive cardiomyopathy; 3. Thrombosis or tumors in the atrium; 4. The anterior posterior diameter of left atrium >55mm (2D echocardiography, parasternal long axis view); 5. Contraindications to heparin or oral anticoagulants; 6. Creatinine clearance rate less than 30ml/min; 7. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Within 12 months of follow-up after "4E" ablation, no episodes of atrial tachyarrhythmias including atrial fibrillation, atrial flutter, and atrial tachycardia and lasting more than 30 seconds without antiarrhythmic drugs, three months after alation was a blank period;

Secondary

MeasureTime frame
Follow up for 12 months after catheter radiofrequency ablation showed no atrial fibrillation events lasting>30 seconds without antiarrhythmic drugs;Follow up for 12 months after catheter radiofrequency ablation showed no atrial flutter events lasting>30 seconds without antiarrhythmic drugs;Follow up for 12 months after catheter radiofrequency ablation showed no atrial tachycardia events lasting>30 seconds without antiarrhythmic drugs;Incidence of complications during the perioperative and follow-up periods;Ablation time;The relationship between intraoperative atrial fibrillation ablation termination and postoperative success rate;

Countries

China

Contacts

Public ContactYong Wei

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

weiyong202@qq.com+86 189 1828 8889

Outcome results

None listed

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