Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation

Phase 3

Completed

• Conditions: Coagulation; Intravascular
• Interventions: Drug: Intermittent heparin infusion; Drug: Continuous heparin infusion

• Registration Number: NCT01935557
• Lead Sponsor: Yong Seog Oh

Brief Summary

Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing during the procedure is important.

Randomized comparison of continuous and intermittent heparin infusion during catheter ablation of Atrial Fibrillation.

Detailed Description

Intravenous heparin was used during the procedure to prevent catheter-induced thrombosis.

heparin is administered during the procedure to achieve recommended activation clotting times (ACT) values, typically \>300 seconds to prevent thromboemboli during the procedure.

Most of the practitioners was that ACT level should be checked at 30- to 60-minute intervals and then have injected intermittently.

intermittent heparin infusion, concentration is great changed because the heparin has 30minutes half-period.

researchers postulate that a constant therapeutic concentrations would be beneficial to continuous infusion than intermittent infusion.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-09-01
• Study First Submitted QC: 2013-09-01
• Study First Posted: 2013-09-05
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

• Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria

• Clinical trial denied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent heparin infusion group	Intermittent heparin infusion	Intermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician.
Continuous heparin infusion group	Continuous heparin infusion	continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.

Primary Outcome Measures

Name	Time	Method
therapeutic ACT retention rate during procedure	2 years

Trial Locations

Locations (1)

Seoul st. mary's hospital; 🇰🇷 Seoul, Korea, Republic of