Please select the eligibility criteria that correspond to the clinical trial below.
Title: Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)
Brief Summary: Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation related to stopping oral anti-coagulant therapy is currently managed by using bridging heparin therapy in patients with moderate to high risk of blood clot formation. There is a substantial risk of bleeding in the pocket where the device is situated (pocket hematoma)related to bridging therapy. The purpose of this study is to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery, with the hypothesis being that the continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to the bridging with heparin group.


Options:
A: Inclusion Criteria:

1. Signed informed consent.
2. \>18 years of age.
3. NVAF with planned catheter ablation treatment.
4. Planned anticoagulant treatment for at least 1 month after the index procedure.
5. Subject agrees to all required follow-up procedures and visits.
6. For women of childbearing potential (WOCBP):

   * Must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
   * Must not be breastfeeding
   * Must agree to follow instructions for method(s) of contraception for a total of 33 days post-treatment completion.
7. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a total of 93 days post-treatment completion.
8. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in this section.

Exclusion Criteria:

1. History of significant bleeding diathesis or coagulopathy or inability to accept blood transfusions.
2. Known hypersensitivity or contraindication to heparin or apixaban.
3. Subjects with mechanical prosthetic heart valves.
4. History of cerebrovascular accident or transient ischemic attach (TIA) within the last 6 months.
5. Prior intracranial hemorrhage.
6. End-stage renal failure (creatinine clearance rate \<15 mL/minute or on dialysis treatment).
7. Hepatic disease associated with coagulopathy.
8. Current or expected systemic treatment with strong dual inducers of CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort).
9. Current or expected systemic treatment with dual antiplatelet therapy, other anticoagulants, or fibrinolytics.
10. Planned or expected surgery, or other invasive procedure that would require interruption of anticoagulation within 1 month of the catheter ablation procedure.
11. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
12. Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the trial.
13. Platelet count ≤100,000/mm3.
14. Hemoglobin level \<9 g/dL.
15. Any active bleeding.
16. Prisoners or subjects who are involuntarily incarcerated.
17. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
B: Inclusion Criteria:

* Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria:

* Clinical trial denied
C: Inclusion Criteria:

1. Any patient undergoing elective device surgery (i.e. de novo device implantation or pulse generator change or lead replacement or pocket revision)
2. Patient at moderate or high risk of arterial thrombo-embolic events (ATE) or high risk of venous thrombo-embolic events (VTE) (defined as one or more of following):

   * Prosthetic mitral valve replacement
   * Caged ball or tilting disc aortic valve prosthesis
   * Bileaflet aortic valve prosthesis and one or more of: AF (atrial Fibrillation/Atrial Flutter), prior stroke or TIA, hypertension, diabetes, CHF age \>75
   * AFib/Flutter associated with rheumatic valvular heart disease
   * Non-rheumatic AFib/Flutter and CHADS2 risk criteria SCORE \> 2
   * Non-rheumatic AFib/Flutter and stroke or TIA (within 3 months)
   * Persistent/permanent AFib/Flutter on day of acceptance for device surgery AND plan for cardioversion or DFT testing at device implant
   * Recent (within 3 months) VTE
   * Severe thrombophilia (Protein C or S deficiency or anti-thrombin or anti-phospholipid antibodies or multiple abnormalities)
3. Willing to self-inject or have a relative or friend or nurse inject LMWH

Exclusion Criteria:

1. Unable ro unwilling to provide informed consent
2. History of noncompliance of medical therapy
3. Renal failure with Cr \> 180 umol/l
4. Prior Heparin induced thrombocytopenia
5. Active device infection
D: Inclusion Criteria:

* Age ≥20 or ≤85 years at time of giving informed consent
* Nonvalvular atrial fibrillation
* History of stroke in previous 6 months
* Current or planned treatment with edoxaban
* Modified Rankin scale ≤3

Exclusion Criteria:

* Symptomatic paroxysmal AF resistant to anti-arrhythmic drugs
* Presence of left atrial thrombus and left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
* Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy.
* Presence of severe renal disorder (estimated creatinine clearance \<30 mL/min by Cockroft-Gault equation)
* Previous CA or surgical intervention for AF
* History of treatment with a left atrial appendage closure device
* Left atrial diameter ≥55 mm on transthoracic echocardiography
* Ejection fraction ≤35% on transthoracic echocardiography
* Persistent AF for ≥10 years
* Pregnant or possibility of pregnancy
* Unlikely to complete the study, such as due to progressive malignant tumor
* Participating or planning to participate in another clinical trial
* Unwilling to participates
* Judged as incompatible for the study by the investigators

Answer: C