NCT07361081

Protocol-Driven Continuous Infusion Versus Intermittent Bolus Heparin During Atrial Fibrillation Ablation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Thromboembolism and bleeding are still the most common encountered complications during atrial fibrillation ablation. The purpose of this study is to investigate a prespecified protocol-driven continuous heparin infusion method comparing intermittent bolus method for an optimal activated clotting time (ACT) in patients during atrial fibrillation (AF) ablation in Asia population. This is a single-center and retrospective cohort study. The prespecified optimal ACT in this study is defined as 250-350 s. The primary outcome is the frequency of achieving optimal ACT during ablation. Safety outcomes are thromboembolic and major or minor bleeding events during or after ablation. Generalized Estimating Equations (GEE) logistic models will be used to analyze the factors associated with insufficient or over ACT events.

Detailed description

This is a single-center and retrospective cohort study. The study will enroll patients above 20 years old and received RF ablation for AF from 2018 to the end of 2020. The baseline characteristics of the patients will be obtained from the electronic medical records, including age, sex, body weight, body height, risk factors of stroke, cardiac echo, laboratory data, and medications. Three experienced attending physicians are involved in the study. Two used the prespecified continuous infusion protocol to adjust heparin doses.

Conditions

• Atrial Fibrillation (AF)
• Ablation

Timeline

• Start date: 2022-09-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: Taiwan