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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Drug: novel oral anticoagulant for 30 days; Drug: novel oral anticoagulant for 24 hour

• Registration Number: NCT02504177
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-19
• Study First Posted: 2015-07-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 433

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The group of keep medication NOAC	novel oral anticoagulant for 30 days	The randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation
The group of stop medication NOAC 1 day	novel oral anticoagulant for 24 hour	The randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation

Primary Outcome Measures

Name	Time	Method
incidence of major bleeding complications	during 30 days post-AF ablation.	Bleeding complication is assessed by physical examination or laboratory measurement

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	during 30 days post-AF ablation.
incidence of thromboembolism	during 30 days post-AF ablation.	thromboembolism is diagnosed by both clinical situations and image studies combined.
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.	vascular complication is diagnosed by both clinical situations and image studies combined.

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of