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Active, Not Recruiting

NCT Number: NCT07361081

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation (AF) Ablation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital,

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 20 years old
  • Received RF ablation for AF from 2018 to the end of 2020

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. the frequency of optimal ACT during whole procedure

    Time frame: 400DAYS

    The primary outcome of this study is the frequency of optimal ACT during whole procedure. The prespecified optimal ACT in this study is defined as 250-350s.

Secondary outcomes

  1. Other effective outcomes

    Time frame: 3 days

    total and initial dose of heparin, total heparin and optimal ACT time, average and standard deviation (SD) of ACT, duration of achieving an optimal ACT, and insufficient, optimal and over ACT after loading heparin.

  2. Safety outcomes

    Time frame: 400DAYS

    Manually reviewed by medical records for thromboembolic and major or minor bleeding during or after ablation.

    Any reason delaying hospital discharge would be recorded.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Acronym: AF HEPARIN

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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