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

NCT ID: NCT03520868

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-05
• Study Completion Date: 2020-03-30

Brief Summary

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.

Detailed 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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Monitoring Anti Factor Xa level

Intervention Type: 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.

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

Monitoring Anti Factor Xa level

Intervention Type: 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.

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

Monitoring Anti Factor Xa level

Intervention Type: 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.

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

Monitoring Anti Factor Xa level

Intervention Type: 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.

Interventions

Monitoring Anti Factor Xa level

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Michael Orlov

Electrophysiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael V Orlov, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

St Elizabeth Medical Center

Brighton, Massachusetts, United States

Countries

United States

Other Identifiers

00747

Identifier Type: -

Identifier Source: org_study_id