Protocol-Driven Continuous Infusion Versus Intermittent Bolus Heparin During Atrial Fibrillation Ablation (AF HEPARIN)

January 14, 2026 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
400DAYS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days
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.
400DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202208043RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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