Oral Anticoagulation Therapy Pilot Study

Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - 90
Start Date:August 1, 2013
End Date:March 31, 2020
Contact:Chris Hendricks
Phone:(909) 839-8447

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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)

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.

Patients undergoing successful cardiac ablation for atrial fibrillation who remain AF
recurrence-free 3 months after successful ablation and continue to meet the
inclusion/exclusion criteria will be screened for enrollment in the trial. After fulfilling
all of the inclusion/exclusion criteria, patients who consent to participate in the study and
remain AF recurrence-free will be randomized to one of two study arms: (1) OAT Withdrawal
(Test) Group or (2) OAT (Control) Group and participate in the Evaluation Period (12 months).

Inclusion Criteria:

1. Successful cardiac ablation for AF

2. 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).

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

4. CHADS2 score ≥ 2 or CHA2DS2-VASc score (≥3)

5. Left ventricular ejection fraction > 25%

6. LA size < 65

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

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

9. Signed informed consent form

10. Age 18 years or older

Exclusion Criteria:

1. OAT required for reasons not related to AF (i.e., prosthetic valve, PV stenosis,
previous pulmonary embolism, presence of spontaneous echo contrast [SEC] at standard
echo performed at 3-months follow-up).

2. Any cardiac surgery within the past 60 days (2 months) or valvular cardiac surgical
procedure at any time (i.e., ventriculotomy, atriotomy, and valve repair or
replacement and presence of a prosthetic valve)

3. Previous myocardial infarction (MI) or a percutaneous coronary intervention PCI within
the past 3 months

4. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12

5. Documented left atrial thrombus

6. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or
COPD) or any other disease or malfunction of the lungs or respiratory system that
produces chronic symptoms

7. Significant medical problem that in the opinion of the investigator would preclude
enrollment in this study

8. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)

9. Acute illness or active systemic infection or sepsis

10. Unstable angina

11. Contraindication to anticoagulation (i.e., heparin, warfarin or another commercially
available anticoagulation medication)

12. History of blood clotting or bleeding abnormalities

13. Life expectancy less than 360 days (12 months)

14. Uncontrolled Heart Failure or NYHA Class III or IV heart failure

15. Enrollment in a clinical study evaluating another device or drug, within the past 6

16. Unable or unwilling to comply with protocol requirements
We found this trial at
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Ohad Ziv, MD
Phone: 216-778-2714
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
Cleveland, OH
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Austin, Texas 78758
Principal Investigator: Andrea Natale, MD
Phone: 512-458-9410
Austin, TX
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Bordeaux, Pessac 33604
Principal Investigator: Pierre Jais, MD
Phone: +33 5 57 62 30 91
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Kansas City, Kansas 66160
Principal Investigator: Dhanunjaya Lakkireddy, MD
Phone: 913-588-5969
Kansas City, KS
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael Riley, MD
Phone: 215-615-5226
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Philadelphia, PA
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