Oral Anticoagulation Therapy Pilot Study
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Off OAT Group (Test); On OAT Group (Control)
Intervention description: Discontinuation of OAT Therapy; Continuation of OAT Therapy
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Anticoagulation; Oral; Paroxysmal atrial fibrillation; Patients post successful cardiac ablation; Symptomatic high-burden paroxysmal AF; 3 months post procedure; Remain free from AF recurrence

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 criteria:

        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
             months)

          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
             months

         16. Unable or unwilling to comply with protocol requirements