Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, cryoablation, irrigated radiofrequency ablation, pulmonary vein isolation
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.
Interventions
PROCEDUREcryoballoon ablation
cryoballoon ablation：pulmonary vein isolation by cryoballoon
PROCEDUREradiofrequency ablation
radiofrequency ablation: pulmonary vein isolation by radiofrequency energy
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| X-ray time (min) | one year | — |
| Procedure time (min) | one year | skin to skin |
| QoL changes at 12 months (Units on a Scale) | one year | — |
| time to first time cardiovascular hospitalization (month) | one year | — |
| Left atrial time (min) | one year | — |
Countries
China
Contacts
Primary ContactQi Jin
Outcome results
None listed