NCT03044951
Unknown
Not Applicable
Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
ConditionsAtrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Ruijin Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Efficacy endpoint (time to first documented clinical recurrence after blanking period)
- Last Updated
- 9 years ago
Overview
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.
Investigators
Qi Jin
Clinical Professor
Ruijin Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Efficacy endpoint (time to first documented clinical recurrence after blanking period)
Time Frame: one year
the time to first documented clinical recurrence after blanking period (month)
Safety endpoint (Any procedure-related complications)
Time Frame: one year
Any procedure-related complications
Secondary Outcomes
- QoL changes at 12 months (Units on a Scale)(one year)
- X-ray time (min)(one year)
- Procedure time (min)(one year)
- Left atrial time (min)(one year)
- time to first time cardiovascular hospitalization (month)(one year)
Study Sites (1)
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