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

NCT07361081 | Active Not Recruiting

• 1 other identifier: 202208043RINB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF); Ablation

Keywords

Atrial Fibrillatio; ablation; Heparin protocol

Outcome Measures

Primary Outcomes (1)

• the frequency of optimal ACT during whole procedure

  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 Outcomes (2)

• Other effective outcomes

  3 days

• Safety outcomes

  400DAYS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital,

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 22, 2026
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

TW (1)