Safety of Oral Anticoagulation Therapy Withdrawal After Successful Cardiac Ablation in Patients With Atrial Fibrillation and Associated High Risk Factors for Embolic Events (OAT Pilot Study)

Status: Terminated
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: No
View:

• Successful cardiac ablation for AF

• Documented freedom from AF recurrence (symptomatic or asymptomatic arrhythmic recurrences lasting longer than 30 seconds) 3 months after successful cardiac ablation (AF recurrence during 3-month blanking period is excluded).

• Patient must have been on a commercially approved anticoagulation therapy for at least two (2) months prior to randomization in the OAT Study.

• CHADS2 score ≥ 2 or CHA2DS2-VASc score (≥3)

• Left ventricular ejection fraction > 25%

• LA size < 65

• High risk for thromboembolic events (i.e., CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3) and require OAT before undergoing cardiac ablation

• Able and willing to comply with all pre- and follow-up testing and requirements

• Signed informed consent form

• Age 18 years or older

Locations
United States
Kansas
University of Kansas Hospitals
Kansas City
Ohio
MetroHealth Medical Center
Cleveland
Pennsylvania
University of Pennsylvania
Philadelphia
Texas
Texas Cardiac Arrhythmia Research Foundation
Austin
Other Locations
France
Le Centre Hospitalier de Bordeaux
Bordeaux
Germany
Asklepios Klinik St. Georg
Hamburg
Italy
Ospedale dell'Angelo
Mestre
Time Frame
Start Date: April 17, 2013
Completion Date: October 7, 2019
Participants
Target number of participants: 80
Treatments
Experimental: Off OAT Group (Test)
Discontinuation of OAT Therapy
Other: On OAT Group (Control)
Continuation of OAT Therapy
Related Therapeutic Areas
Sponsors
Leads: Biosense Webster, Inc.

This content was sourced from clinicaltrials.gov

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