A pilot study comparing short and long term change of heart rate variability after radiofrequency ablation and cryoballoon ablation for atrial fibrillation using 14-day novel adhesive patch electrocardiographic monitoring

Not Applicable

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0005306
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

?Male or female patients between 18 - 80 years old
?Atrial fibrillation documented on electrocardiography
?Atrialrial fibrillation refractory to more than one antiarrhythmic or cannot use the antiarrhythmic for its adverse effect
?Sinus rhythm before procedure
?Agree to the study protocol and provide written informed consent

Exclusion Criteria

?Those with conflict of interest
?cannot understand or accept the study protocol
?Persistent atrial fibrillation before procedure
?Anatomical variations not suitable for either RF or CB ablation
?Common pulmonary vein ostium
?Left atrial anterior – posterior diameter > 55mm
?Pulmonary vein ostial size > 26mm
?Active liver disease or liver dysfunction (ALT or AST > x3 normal range)
?Severe congestive heart failure (NYHA Class III or IV)
?Active malignancy
?Pregnancy or breastfeeding
?Life expectancy < 1 year
?Not suitable for participation by attending physician's discretion

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short term change of heart rate variability during 2-weeks after pulmonary vein isolation

Secondary Outcome Measures

Name	Time	Method
ong term change of heart rate variability at 3 and 6 months after pulmonary vein isolation;Recurrence of atrial fibrillation at 3 and 6 months after pulmonary vein isolation