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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520868
• Other study ID #: 00747
• Status: Completed
• Start date: May 5, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2021
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	St Elizabeth Medical Center	Brighton	Massachusetts

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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