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Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02504177
Enrollment
433
Registered
2015-07-21
Start date
2015-06-30
Completion date
2019-06-30
Last updated
2019-02-15

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

Conditions

Atrial Fibrillation

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.

Interventions

DRUGnovel oral anticoagulant for 30 days

novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

DRUGnovel oral anticoagulant for 24 hour

novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients who consent with study 2. Patients with Atrial fibrillation (20-80 years old) 3. patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation 4. Patients possible to NOAC

Exclusion criteria

1. Patients who do not agree with study inclusion 2. eGRF \< 30ml/min 3. Impossible to NOAC 4. Structural cardiac disease 5. Major hemorrhagic complication 6. CHA2DS2-VASc score \> 5 7. Patients who have experienced Ischemic cerebellar infarction more than 2times

Design outcomes

Primary

MeasureTime frameDescription
incidence of major bleeding complicationsduring 30 days post-AF ablation.Bleeding complication is assessed by physical examination or laboratory measurement

Secondary

MeasureTime frameDescription
incidence of thromboembolismduring 30 days post-AF ablation.thromboembolism is diagnosed by both clinical situations and image studies combined.
incidence of minor bleedingduring 30 days post-AF ablation.
Re-admission rate related procedureduring 30 days post-AF ablation.
length of hospital stayduring 30 days post-AF ablation.
incidence of vascular complicationsduring 30 days post-AF ablation.vascular complication is diagnosed by both clinical situations and image studies combined.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026