Heparin Requirements in Patients Undergoing Atrial Fibrillation Ablation on Coumadin vs NOACs

Steward St. Elizabeth's Medical Center of Boston, Inc.

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: Monitoring Anti Factor Xa level

Study type: Observational

Funder types: Other

Identifiers

NCT03520868

00747

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All adults, male and female, aged 18 and above.
• Patients with paroxysmal, persistent or chronic AF
• All patients must be on therapeutic doses of Coumadin or one of the NOACs for at least 1 month prior to the procedure.

Exclusion criteria

• Patients with known primary or secondary coagulopathy (such as Hemophilia, vWF deficiency, active malignancy, ATIII deficiency, Factor V Leiden deficiency, Hx of recurrent DVT/PE)
• Patients with hypoalbuminemia, cirrhosis
• chronic LMWH therapy,
• ESRD on HD, and severely impaired kidney function with CKD stage IV
• BMI >35
• prosthetic heart valves and
• advanced liver disease
• previous procedural complications such as tamponade

Trial design

60 participants in 4 patient groups

Coumadin

Description:

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

Treatment:

Diagnostic Test: Monitoring Anti Factor Xa level

Dabigatran

Description:

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

Treatment:

Diagnostic Test: Monitoring Anti Factor Xa level

Rivaroxiban

Description:

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

Treatment:

Diagnostic Test: Monitoring Anti Factor Xa level

Apixaban

Description:

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

Treatment:

Diagnostic Test: Monitoring Anti Factor Xa level