NCT03520868|Completed
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Sponsor study identifier
observational
60
1 country
1
Study Start
May 5, 2017
Actual (reported)Primary Completion
March 30, 2020
Actual (reported)Study Completion
March 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2020
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2017
Actual (reported)October 31, 2017
Actual (reported)May 11, 2018
Actual (reported)March 30, 2020
Actual (reported)March 30, 2020
Actual (reported)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
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
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
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
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All adults, male and female, aged 18 and above, who have been referred to the EP lab for elective PVI (Pulmonary Vein Isolation).
St Elizabeth Medical Center
Brighton, Massachusetts, 02135, United States
Serum blood test
Michael V Orlov, MD
Steward St. Elizabeth's Medical Center of Boston, Inc.
60 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2017
First Posted
May 11, 2018
Study Start
May 5, 2017
Actual (reported)SDM for Stroke Prevention in Atrial Fibrillation
Contact the study team to confirm eligibility.
Primary Completion
March 30, 2020
Actual (reported)Study Completion
March 30, 2020
Actual (reported)Last Updated
July 16, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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