Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Yonsei University
- Enrollment
- 433
- Locations
- 1
- Primary Endpoint
- incidence of major bleeding complications
Study Overview
Brief Summary
This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients who stop NOAC in the morning of the procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who consent with study
- •Patients with Atrial fibrillation (20-80 years old)
- •patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
- •Patients possible to NOAC
Exclusion Criteria
- •Patients who do not agree with study inclusion
- •eGRF < 30ml/min
- •Impossible to NOAC
- •Structural cardiac disease
- •Major hemorrhagic complication
- •CHA2DS2-VASc score > 5
- •Patients who have experienced Ischemic cerebellar infarction more than 2times
Arms & Interventions
The group of keep medication NOAC
The randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation
Intervention: novel oral anticoagulant for 30 days (Drug)
The group of stop medication NOAC 1 day
The randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation
Intervention: novel oral anticoagulant for 24 hour (Drug)
Outcomes
Primary Outcomes
incidence of major bleeding complications
Time Frame: during 30 days post-AF ablation.
Bleeding complication is assessed by physical examination or laboratory measurement
Secondary Outcomes
- length of hospital stay(during 30 days post-AF ablation.)
- incidence of thromboembolism(during 30 days post-AF ablation.)
- incidence of minor bleeding(during 30 days post-AF ablation.)
- Re-admission rate related procedure(during 30 days post-AF ablation.)
- incidence of vascular complications(during 30 days post-AF ablation.)