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Arterial Versus Venous Activated Clotting Time (ACT) Measurements During Atrial Fibrillation Ablations

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venous ACT
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult scheduled for routine atrial ablation procedure

Exclusion Criteria:

None

Sites / Locations

  • Duke Health Raleigh

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm study

Arm Description

To establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation. Analyses will examine the relationship and agreement between venous and arterial ACTs.

Outcomes

Primary Outcome Measures

Proportion of venous ACT samples that match arterial ACT sample results during atrial fibrillation ablation
Paired samples pre and during the ablation procedure

Secondary Outcome Measures

Full Information

First Posted
February 24, 2020
Last Updated
June 25, 2021
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04285840
Brief Title
Arterial Versus Venous Activated Clotting Time (ACT) Measurements During Atrial Fibrillation Ablations
Official Title
Arterial Versus Venous Activated Clotting Time Measurements During Atrial Fibrillation Ablations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Activated clotting times (ACTs) are routinely measured throughout atrial fibrillation ablations to monitor anticoagulation prior to and after heparin administration. Routinely, ACTs are obtained from an arterial line established prior to heparin administration. With technological advances, the cardiac intervention team is interested in eliminating the need for arterial lines for noninvasive monitoring devices; eliminating arterial lines could decrease the risk of bleeding, infection, and pain. Since procedural access requires femoral vein catheterization, obtaining ACTs through the venous sheath would not pose additional risks to the patient. In this study it proposed to draw paired arterial and venous ACT samples in ablation procedures to compare the agreement between venous and arterial ACTs for adequate patient treatment planning.
Detailed Description
This project aims to establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation in 50 adults. Analyses will examine the relationship and agreement between venous and arterial ACTs. It is anticipated that the standardized procedure could eliminate the need for an arterial line for ACT measurement which would reduce patient risks for bleeding, infection, and discomfort. Patients who are scheduled for for atrial fibrillation ablations will be invited to participate in this project. An information sheet will be provided about the project to potential participants. If the potential participant expresses interest, a study specific consent consent will be obtained to allow the additional paired blood samples to be drawn throughout the procedure. The additional blood volume to be drawn is expected to be less than or equal to a teaspoon of venous blood. Participation will be completely voluntary. Patients will undergo usual standard of care for the procedure, including usual arterial and venous sheath/catheter insertions. After obtaining venous and arterial access, baseline ACTs will be drawn using the outlined ACT sampling procedure. The ACT value for both arterial and venous samples will be obtained using the standard procedure for Hemochron Signature Elite point-of-care testing; this test uses less than 0.5 cc blood. ACT samples will be performed at baseline (pre-heparin administration), every 30 minutes during the procedure (per standard ACT monitoring protocol to obtain and maintain desired ACT), and at the end of procedure prior to arterial and venous sheath removal. Time of procedure ranges from 2 to 4 hours and may result in a minimum of 2 paired samples (pre and end) to a maximum of 9 paired samples (pre, end, and every 30 minutes) per patient; this equates to an additional 1 cc to 4.5 cc of additional blood for paired sampling per patient. ACT arterial and venous sampling procedure: Using a stopcock at the nearest point of insertion, withdraw 30 cc of blood in a syringe; turn the stopcock and remove 0.5cc of blood for ACT testing; turn the stopcock to return the 30 cc blood and flush the line; remove the syringe with the ACT sample and flush the line with saline, replace syringes for the next ACT sampling process. Patients undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this project. The purpose for paired sampling is to verify that the proposed venous sampling method is accurate and provides an evaluable sample to compare with the ACT sample results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Other
Arm Description
To establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation. Analyses will examine the relationship and agreement between venous and arterial ACTs.
Intervention Type
Other
Intervention Name(s)
Venous ACT
Intervention Description
Matched/paired venous ACT samples will be drawn at the same time as arterial ACT samples to compare the results agreement between venous and arterial ACTs. Subjects undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this study.
Primary Outcome Measure Information:
Title
Proportion of venous ACT samples that match arterial ACT sample results during atrial fibrillation ablation
Description
Paired samples pre and during the ablation procedure
Time Frame
Day of atrial fibrillation ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult scheduled for routine atrial ablation procedure Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Deborah, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Health Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Arterial Versus Venous Activated Clotting Time (ACT) Measurements During Atrial Fibrillation Ablations

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