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Status unknownNCT02504177Updated Feb 15, 2019

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

An interventional study of novel oral anticoagulant for 30 days and novel oral anticoagulant for 24 hour in Atrial Fibrillation, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
433
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atrial Fibrillation

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In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 433 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
433 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Drugnovel oral anticoagulant for 30 days

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

  • Drugnovel oral anticoagulant for 24 hour

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

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What researchers measure

Primary outcomes

  1. incidence of major bleeding complications

    Bleeding complication is assessed by physical examination or laboratory measurement

    Time frame: during 30 days post-AF ablation.

Secondary outcomes

  1. incidence of thromboembolism

    thromboembolism is diagnosed by both clinical situations and image studies combined.

    Time frame: during 30 days post-AF ablation.

  2. incidence of minor bleeding

    Time frame: during 30 days post-AF ablation.

  3. Re-admission rate related procedure

    Time frame: during 30 days post-AF ablation.

  4. length of hospital stay

    Time frame: during 30 days post-AF ablation.

  5. incidence of vascular complications

    vascular complication is diagnosed by both clinical situations and image studies combined.

    Time frame: during 30 days post-AF ablation.

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Study locations

1 of 1 sites recruiting
  • Severance Cardiovascular Hospital, Yonsei University Health System
    Seoul, 120-752, South Korea
    • Hui-Nam Pak, M.D., Ph.D. · Contact · hnpak@yuhs.ac · 82-2-2228-8459
    Recruiting
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Jun 2019 and a completion of Jun 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2015
First posted
Jul 21, 2015
Start
Jun 2015
Primary completionEst.
Jun 2019
CompletionEst.
Jun 2019
Last update
Feb 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02504177
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 21, 2015
Start date
Jun 2015
Primary completion
Jun 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Feb 15, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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