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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: radiofrequency ablation; Procedure: cryoballoon ablation

• Registration Number: NCT03044951
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-30
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-06
• Last Update Submitted: 2017-02-06
• Study First Posted: 2017-02-07
• Last Update Posted: 2017-02-07
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiofrequency ablation	radiofrequency ablation	patients who accept radiofrequency ablation
cryoballoon ablation	cryoballoon ablation	patients who accept cryoballoon ablation

Primary Outcome Measures

Name	Time	Method
Efficacy endpoint (time to first documented clinical recurrence after blanking period)	one year	the time to first documented clinical recurrence after blanking period (month)
Safety endpoint (Any procedure-related complications)	one year	Any procedure-related complications

Secondary Outcome Measures

Name	Time	Method
QoL changes at 12 months (Units on a Scale)	one year
X-ray time (min)	one year
Procedure time (min)	one year	skin to skin
Left atrial time (min)	one year
time to first time cardiovascular hospitalization (month)	one year

Trial Locations

Locations (1)

Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China