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

February 14, 2019 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

433

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Cardiovascular Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The group of keep medication NOAC
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
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
Active Comparator: The group of stop medication NOAC 1 day
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
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of major bleeding complications
Time Frame: during 30 days post-AF ablation.
Bleeding complication is assessed by physical examination or laboratory measurement
during 30 days post-AF ablation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of thromboembolism
Time Frame: during 30 days post-AF ablation.
thromboembolism is diagnosed by both clinical situations and image studies combined.
during 30 days post-AF ablation.
incidence of minor bleeding
Time Frame: during 30 days post-AF ablation.
during 30 days post-AF ablation.
Re-admission rate related procedure
Time Frame: during 30 days post-AF ablation.
during 30 days post-AF ablation.
length of hospital stay
Time Frame: during 30 days post-AF ablation.
during 30 days post-AF ablation.
incidence of vascular complications
Time Frame: during 30 days post-AF ablation.
vascular complication is diagnosed by both clinical situations and image studies combined.
during 30 days post-AF ablation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 19, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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