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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Monitoring Anti Factor Xa level

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • St Elizabeth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults, male and female, aged 18 and above, who have been referred to the EP lab for elective PVI (Pulmonary Vein Isolation).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: 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.
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	Diagnostic test: 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.
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	Diagnostic test: 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.
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	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	The intra-procedural heparin activity is measured using ACT	During the procedure

Collaborators and Investigators

• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Investigators: Principal Investigator: Michael V Orlov, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 00747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No