NCT04942834

Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation

Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.

Detailed description

Subjects with persistent atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.

Conditions

• Atrial Fibrillation, Persistent
• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DRUG	Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone	Class I or III antiarrhythmic drug, including sotalol
DEVICE	cryoballoon ablation	Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-07-01
• Completion: 2026-01-01
• First posted: 2021-06-29
• Last updated: 2024-04-26

Locations

17 sites across 1 country: China