Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01607359

Enrollment

Registered

2012-05-30

Start date

2012-05-31

Completion date

2017-04-20

Last updated

2023-05-11

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, catheter ablation, dabigatran, warfarin, oral anticoagulation

Brief summary

Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.

Detailed description

* Data from patients collected from 4 US and 1 Canadian medical center * Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011. * Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period. * Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period. * Warfarin patients will be numbered sequentially * A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator. Patient data sets will be de-identified and compiled * Master data set to be stored in Excel file * Statistics to be performed with SAS (Cary, NC) * Continuous data to be expressed as means ± S.D., compared with unpaired t-tests * Categorical data will be compared with Fisher's exact test or Chi-square * Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients undergoing catheter ablation for atrial fibrillation

Exclusion criteria

* none (retrospective trial)

Design outcomes

Primary

Measure	Time frame	Description
Clinical stroke, TIA or systemic embolic complication	30 days before or after catheter ablation	Thromboembolic complication recorded in clinical records.
Bleeding complication	30 days before or after catheter ablation	Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.

Secondary

Measure	Time frame	Description
Any significant complication	30 days before or after catheter ablation	Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen

Countries

United States

Outcome results