Oral Anticoagulation Therapy Pilot Study

Phase 4TerminatedNCT01959425

Biosense Webster, Inc.80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Off OAT Group (Test)OTHER

Discontinuation of OAT Therapy

On OAT Group (Control)OTHER

Continuation of OAT Therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 12 months

Percentage of Expired Participants

All cause mortality during the 12-month Evaluation Period.

Time frame: 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.

Time frame: Baseline, 3 months, 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.