This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.
Subjects with atrial fibrillation and heart failure with different ejection fraction categories are devided to either an anti-arrhythmic drug or cryoballoon catheter ablation.
Study Type
OBSERVATIONAL
Enrollment
200
Propafenone, Sotalol and Amiodarone
Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters including 23mm and 28mm.
Affiliated hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGTreatment success at one year
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: one year
Rate of adverse events
Rate of complications and adverse events occurred during cryoballoon ablation and postoperative follow-up, including all-cause mortality, rehospitalisation for HF, and the composite event of all-cause mortality or HF hospitalisation
Time frame: one year
Arrhythmia recurrence during blanking period
atrial tachycardia recurrence
Time frame: 3 months
Quality of life changes at 12 months measured by 12-Item Short Form Survey (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) with the values ranging from 12 - 47 (higher scores mean a worse outcome)
Time frame: one year
Quality of life changes at 12 months measured by AF Quality of Life Survey (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) with the values ranging from 20 - 140 (higher scores mean a worse outcome)
Time frame: one year
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