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

Yonsei University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Drug: novel oral anticoagulant for 24 hour; Drug: novel oral anticoagulant for 30 days

Study type: Interventional

Funder types: Other

Identifiers

NCT02504177

4-2015-0387

Details and patient eligibility

About

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.

Enrollment: 433 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

433 participants in 2 patient groups

The group of keep medication NOAC

Experimental group

Description:

The randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation

Treatment:

Drug: novel oral anticoagulant for 30 days

The group of stop medication NOAC 1 day

Active Comparator group

Description:

The randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation

Treatment:

Drug: novel oral anticoagulant for 24 hour