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

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02504177
• Other study ID #: 4-2015-0387
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 433
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• novel oral anticoagulant for 30 days
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
• novel oral anticoagulant for 24 hour
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of major bleeding complications	Bleeding complication is assessed by physical examination or laboratory measurement	during 30 days post-AF ablation.
Secondary	incidence of thromboembolism	thromboembolism is diagnosed by both clinical situations and image studies combined.	during 30 days post-AF ablation.
Secondary	incidence of minor bleeding		during 30 days post-AF ablation.
Secondary	Re-admission rate related procedure		during 30 days post-AF ablation.
Secondary	length of hospital stay		during 30 days post-AF ablation.
Secondary	incidence of vascular complications	vascular complication is diagnosed by both clinical situations and image studies combined.	during 30 days post-AF ablation.