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

NCT04285840 | Completed

• 1 other identifier: Pro00104539
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Proportion of venous ACT samples that match arterial ACT sample results during atrial fibrillation ablation

  Paired samples pre and during the ablation procedure

  Day of atrial fibrillation ablation procedure

Study Arms (1)

Single arm study

OTHER

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.

Other: Venous ACT

Interventions

Venous ACT OTHER

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.

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult scheduled for routine atrial ablation procedure

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Health Raleigh

Raleigh, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Allen Deborah, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: February 10, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)