This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.
Subjects with persistent atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Class I or III antiarrhythmic drug, including sotalol
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
Fujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGTreatment success at 12 months
Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.
Time frame: Randomization to 12 months
Rate of serious adverse events
Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure
Time frame: Randomization to 12 months
Quality of life changes at 12 months measured by AFEQT
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT)
Time frame: one year
Quality of life changes at 12 months measured by SF-12
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12)
Time frame: one year
Arrhythmia recurrence during blanking period
atrial tachycardia recurrence rate during the blanking period
Time frame: 3 months
time to first time cardiovascular hospitalization (month)
time to first time cardiovascular hospitalization after treatment (month)
Time frame: one year
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Dongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGNanjing Drum Tower hospital
Nanjing, Jiangsu, China
RECRUITINGZhongda Hospital Southeast University
Nanjing, Jiangsu, China
RECRUITINGAffiliated Hospital Of Nantong University
Nantong, Jiangsu, China
RECRUITINGJiangsu Taizhou People's Hospital
Taizhou, Jiangsu, China
RECRUITINGXuzhou Central Hospital
Xuzhou, Jiangsu, China
RECRUITING...and 7 more locations