It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
cryoballoon ablation：pulmonary vein isolation by cryoballoon
radiofrequency ablation: pulmonary vein isolation by radiofrequency energy
Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGEfficacy endpoint (time to first documented clinical recurrence after blanking period)
the time to first documented clinical recurrence after blanking period (month)
Time frame: one year
Safety endpoint (Any procedure-related complications)
Any procedure-related complications
Time frame: one year
Procedure time (min)
skin to skin
Time frame: one year
Left atrial time (min)
Time frame: one year
X-ray time (min)
Time frame: one year
time to first time cardiovascular hospitalization (month)
Time frame: one year
QoL changes at 12 months (Units on a Scale)
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.