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To observe, using a prospectively designed study, the effect of type of oral anticoagulant on intra-procedural heparin requirements in patients undergoing Atrial Fibrillation ablation and to assess whether ACT assay accurately reflects heparin anti coagulation effect.
Atrial fibrillation (AF) is the most common arrhythmia affecting the US population and accounts for 15% of strokes worldwide. Radiofrequency ablation has become a frequently used therapy for treatment of afib after failure of at least one anti-arrhythmic drug. Pulmonary Vein Isolation (PVI) remains the cornerstone of AF ablation and requires transseptal puncture and placement of catheters in the left atrium which can be thrombogenic and cause stroke. This is avoided by intra-procedural infusion of heparin and the anti-coagulation effect is monitored using Activated Clotting Time (ACT). With the approval of Novel Oral Anti-Coagulants (NOAC), increasing number of patients are undergoing AF ablation on these medications. It has been observed that patients on NOACs require much larger doses of heparin and take longer time to reach therapeutic ACT. Consequently, patients are at higher risk for thromboembolism and stroke. On the other hand, higher doses of heparin can expose patients to excessive bleeding complications. The investigators seek to explain the mechanism of "heparin resistance" in such a patient population and to develop a protocol that can achieve therapeutic anticoagulation quicker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coumadin | Coumadin patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 70 U/kg |
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| Dabigatran | Dabigatran patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 110 U/kg |
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| Rivaroxiban | Rivaroxiban patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 110 U/kg |
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| Apixaban | Apixaban patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 10 U/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring Anti Factor Xa level | Diagnostic Test | Each patient will have baseline Anti-Factor Xa assay checked. During the procedure, Anti-Factor Xa assay is checked concurrently with ACT after heparin bolus and infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-procedural Heparin Requirements in patients taking NOACs and Coumadin | The investigators will measure the amount of intravenous heparin administered to each patient during the afib ablation to achieve therapeutic anticoagulation. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Anti Factor Xa assay measured to assess Heparin activity during Atrial Fibrillation Ablation | The intra-procedural heparin activity is measured using Anti Factor Xa assay. | During the procedure |
| Activated Clotting Time (ACT) measured to assess Heparin activity during Atrial Fibrillation Ablation |
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Inclusion Criteria:
Exclusion Criteria:
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All adults, male and female, aged 18 and above, who have been referred to the EP lab for elective PVI (Pulmonary Vein Isolation).
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| Name | Affiliation | Role |
|---|---|---|
| Michael V Orlov, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Elizabeth Medical Center | Brighton | Massachusetts | 02135 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Serum blood test
The intra-procedural heparin activity is measured using ACT |
| During the procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |