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

NCT01607359 | Withdrawn

• 1 other identifier: 2007088
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Clinical stroke, TIA or systemic embolic complication

  Thromboembolic complication recorded in clinical records.

  30 days before or after catheter ablation

• Bleeding complication

  Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.

  30 days before or after catheter ablation

Secondary Outcomes (1)

• Any significant complication

  30 days before or after catheter ablation

Study Arms (2)

dabigatran group

All patients receiving dabigatran as periprocedural anticoagulation during the study time period

warfarin group

A randomly selected group of patients treated with warfarin during the study time period matching the number of dabigatran treated patients in the same time period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing catheter ablation for atrial fibrillation

You may qualify if:

• All patients undergoing catheter ablation for atrial fibrillation

You may not qualify if:

• none (retrospective trial)

Sponsors & Collaborators

• Corewell Health East: lead
• University of Pennsylvania: collaborator
• Johns Hopkins University: collaborator
• London Health Sciences Centre: collaborator

Study Sites (1)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 30, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: April 20, 2017
• Last Updated: May 11, 2023

Record last verified: 2016-12

Locations

US (1)