Oral Anticoagulation Therapy Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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)

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Other: Off OAT Group (Test)
* Other: On OAT Group (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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). 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) Previous myocardial infarction (MI) or a percutaneous coronary intervention PCI within the past 3 months Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months) Documented left atrial thrombus 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 Significant medical problem that in the opinion of the investigator would preclude enrollment in this study Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) Acute illness or active systemic infection or sepsis Unstable angina Contraindication to anticoagulation (i.e., heparin, warfarin or another commercially available anticoagulation medication) History of blood clotting or bleeding abnormalities Life expectancy less than 360 days (12 months) Uncontrolled Heart Failure or NYHA Class III or IV heart failure Enrollment in a clinical study evaluating another device or drug, within the past 6 months Unable or unwilling to comply with protocol requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Off OAT Group (Test)<br>Discontinuation of OAT Therapy | Other: Off OAT Group (Test)<br>* Discontinuation of OAT Therapy<br>|
| Other: On OAT Group (Control)<br>Continuation of OAT Therapy | Other: On OAT Group (Control)<br>* Continuation of OAT Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Occurrence of Any Major Thromboembolic Event | Composite endpoint represented by the occurrence of any major thromboembolic event (stroke [i.e., ischemic, hemorrhagic or cryptogenic] that is an acute onset of a focal neurologic deficit of presumed vascular origin lasting for ≥24 hours or resulting in death) or major hemorrhagic complication (major bleeding) during the 12-month Evaluation Period. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Minor Bleeds | Any clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period. | 12 months | 
| Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event | Hospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period. | 12 months | 
| Percentage of Expired Participants | All cause mortality during the 12-month Evaluation Period. | 12 months | 
| Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS) | The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability. | Baseline, 3 months, 12 months | 
| Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS) | The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability. | Baseline, 3 months, 12 months | 
| Percentage of Participants With Atrial Fibrillation Recurrence | Recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects with recurrence of atrial fibrillation were immediately exited from the study. | 12 months | 
| Percentage of Participants With Repeat Ablation | Repeat ablations performed due to recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects that required a repeat ablation were immediately exited from the study. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation, Oral, Paroxysmal atrial fibrillation, Patients post successful cardiac ablation, Symptomatic high-burden paroxysmal AF, 3 months post procedure, Remain free from AF recurrence