Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）

Shanghai Jiao Tong University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: radiofrequency ablation; Procedure: cryoballoon ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03044951

DLY201604

Details and patient eligibility

About

It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.

Full description

The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECG recording of atrial fibrillation
• first time of ablation
• refractory to at least one anti-arrhythmia drug
• sign informed consent for participation in the study

Exclusion criteria

• had ablation before
• serious heart failure
• left atrial diameter>55mm
• Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
• Stroke in 6 months before the ablation
• Endocardial thrombosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 2 patient groups

cryoballoon ablation

Experimental group

Description:

patients who accept cryoballoon ablation

Treatment:

Procedure: cryoballoon ablation

radiofrequency ablation

Active Comparator group

Description:

patients who accept radiofrequency ablation

Treatment:

Procedure: radiofrequency ablation