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

NCT ID: NCT01935557

Last Updated: 2016-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Coagulation; Intravascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Continuous heparin infusion group

continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.

Group Type ACTIVE_COMPARATOR

Continuous heparin infusion

Intervention Type DRUG

continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.

Intermittent heparin infusion group

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.

Group Type ACTIVE_COMPARATOR

Intermittent heparin infusion

Intervention Type DRUG

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.

Interventions

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Continuous heparin infusion

continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria

* Clinical trial denied
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yong Seog Oh

OTHER

Sponsor Role lead

Responsible Party

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Yong Seog Oh

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yong Seog Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul st. mary's hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim TS, Kim SH, Kim BK, Kim JY, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Randomized Comparison of Continuous Versus Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2016 Jun;2(3):319-326. doi: 10.1016/j.jacep.2015.11.004. Epub 2015 Dec 9.

Reference Type DERIVED
PMID: 29766891 (View on PubMed)

Other Identifiers

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COHERE

Identifier Type: -

Identifier Source: org_study_id

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