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

NCT02504177 | Unknown

• 1 other identifier: 4-2015-0387
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• incidence of major bleeding complications

  Bleeding complication is assessed by physical examination or laboratory measurement

  during 30 days post-AF ablation.

Secondary Outcomes (5)

• 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.

• length of hospital stay

  during 30 days post-AF ablation.

• incidence of vascular complications

  during 30 days post-AF ablation.

Study Arms (2)

The group of keep medication NOAC

EXPERIMENTAL

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

Drug: novel oral anticoagulant for 30 days

The group of stop medication NOAC 1 day

ACTIVE COMPARATOR

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

Drug: novel oral anticoagulant for 24 hour

Interventions

novel oral anticoagulant for 30 days DRUG

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

The group of keep medication NOAC

novel oral anticoagulant for 24 hour DRUG

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

The group of stop medication NOAC 1 day

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 21, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

KR (1)