Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02313584

Enrollment

464

Registered

2014-12-10

Start date

2014-12-31

Completion date

2017-09-30

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Thromboembolism

Keywords

dabigatran

Brief summary

The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.

Interventions

DRUGdabigatran

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* paroxysmal AF undergoing catheter ablation * CHA2DS2-VASc score \<= 1 * informed consent

Exclusion criteria

* persistent AF * CHA2DS2-VASc score \> 2 * prior CVA * prior atnicoagulant * severe HF * abnormal liver or renal function * history of severe bleeding

Design outcomes

Primary

Measure	Time frame
The rate of thromboembolic events	2 months

Contacts

Primary ContactYoung-Hoon Kim

yhkmd@unitel.co.kr82-2-920-6700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026