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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005306
Enrollment
40
Registered
2020-08-11
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : We will enroll the 40 paroxysmal atrial fibrillation patients who refractory to the anti-arrhythmic medications and requiring pulmonary vein isolation, either using radiofrequency

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Short term change of heart rate variability during 2-weeks after pulmonary vein isolation

Secondary

MeasureTime frame
Long 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

Countries

Korea, Republic of

Contacts

Public ContactGi byoung Nam

Asan Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026