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Comparison of the Efficacy of Pulmonary Vein Isolation Combined with Cavotricuspid Isthmus Ablation in Patients with Paroxysmal Atrial Fibrillation and Atrial Flutter

Comparison of Efficacy Between Pulmonary Vein Isolation and Combined Cavotricuspid Isthmus Ablation in Patients with Paroxysmal Atrial Fibrillation and Atrial Flutter: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120699
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-03-22
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Paroxysmal Atrial Fibrillation and Atrial Flutter

Interventions

Simple loop pulmonary vein isolation group:Radiofrequency Ablation: Left atrial model constructed under 3D navigation guidance, circumferential pulmonary vein isolation (CPVI) performed using a pressu
Combined Ablation Group:Radiofrequency Ablation: Left atrial model constructed under 3D navigation guidance, circumferential pulmonary vein isolation (CPVI) performed using a pressure-sensing catheter

Sponsors

Nanjing Medical University First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patient selection: Diagnosed with paroxysmal atrial fibrillation and accompanied by recorded atrial flutter (at least one episode of AF and AFL confirmed by 12-lead electrocardiogram, 24-hour ambulatory electrocardiogram or clinical records, which can coexist or be recorded separately by multiple electrocardiograms, and AFL can terminate spontaneously or convert to atrial fibrillation, with the duration of AFL episode < 12 hours). 2. Radiofrequency ablation therapy: Patients who have undergone circumferential pulmonary vein isolation or have undergone (or not) isthmus ablation of the tricuspid valve simultaneously. 3. Postoperative data: A 12-lead electrocardiogram is required after ablation

Exclusion criteria

Exclusion criteria: 1. History of previous cardiac ablation surgery; 2. Presence of severe structural heart disease (moderate or severe mitral regurgitation, hereditary hypertrophic cardiomyopathy, dilated cardiomyopathy, or other severe valvular diseases); 3. Thyroid dysfunction; 4. Contraindication to anticoagulation or inability/unwillingness to adhere to standard anticoagulation; 5. Patients unable or unwilling to commit to completing the scheduled follow-up as per the protocol

Design outcomes

Primary

MeasureTime frame
Freedom from sustained supraventricular tachycardia lasting =30 seconds without antiarrhythmic drugs at 3 months post-single ablation procedure;

Secondary

MeasureTime frame
Incidence of intraoperative complications including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and death;Total operative time;Fluoroscopy time;Radiofrequency ablation time;

Countries

China

Contacts

Public ContactChen Hongwu

Nanjing Medical University First Affiliated Hospital

chenhongwu@njmu.edu.cn+86 159 9629 1298

Outcome results

None listed

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