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

NCT03520868 | Completed

• 1 other identifier: 00747
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anti Factor Xa assay measured to assess Heparin activity during Atrial Fibrillation Ablation

  During the procedure

• Activated Clotting Time (ACT) measured to assess Heparin activity during Atrial Fibrillation Ablation

  During the procedure

Study Arms (4)

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

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

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

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

Interventions

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.

Apixaban; Coumadin; Dabigatran; Rivaroxiban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St Elizabeth Medical Center

Brighton, Massachusetts, 02135, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum blood test

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael V Orlov, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Electrophysiologist

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: May 11, 2018
• Study Start: May 5, 2017
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)