Back to resultsClinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
novel oral anticoagulant for 30 days
novel oral anticoagulant for 24 hour
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who do not agree with study inclusion
- 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
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The group of keep medication NOAC
The group of stop medication NOAC 1 day
Arm Description
The randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation
The randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation
Outcomes
Primary Outcome Measures
incidence of major bleeding complications
Bleeding complication is assessed by physical examination or laboratory measurement
Secondary Outcome Measures
incidence of thromboembolism
thromboembolism is diagnosed by both clinical situations and image studies combined.
incidence of minor bleeding
Re-admission rate related procedure
length of hospital stay
incidence of vascular complications
vascular complication is diagnosed by both clinical situations and image studies combined.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02504177
Brief Title
Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
433 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The group of keep medication NOAC
Arm Type
Experimental
Arm Description
The randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation
Arm Title
The group of stop medication NOAC 1 day
Arm Type
Active Comparator
Arm Description
The randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation
Intervention Type
Drug
Intervention Name(s)
novel oral anticoagulant for 30 days
Intervention Description
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
Intervention Type
Drug
Intervention Name(s)
novel oral anticoagulant for 24 hour
Intervention Description
novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
Primary Outcome Measure Information:
Title
incidence of major bleeding complications
Description
Bleeding complication is assessed by physical examination or laboratory measurement
Time Frame
during 30 days post-AF ablation.
Secondary Outcome Measure Information:
Title
incidence of thromboembolism
Description
thromboembolism is diagnosed by both clinical situations and image studies combined.
Time Frame
during 30 days post-AF ablation.
Title
incidence of minor bleeding
Time Frame
during 30 days post-AF ablation.
Title
Re-admission rate related procedure
Time Frame
during 30 days post-AF ablation.
Title
length of hospital stay
Time Frame
during 30 days post-AF ablation.
Title
incidence of vascular complications
Description
vascular complication is diagnosed by both clinical situations and image studies combined.
Time Frame
during 30 days post-AF ablation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients who do not agree with study inclusion
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
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Nam Pak, M.D., Ph.D.
Phone
82-2-2228-8459
Email
hnpak@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation
We'll reach out to this number within 24 hrs