NCT01935557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

September 1, 2013

Last Update Submit

April 13, 2016

Conditions

Keywords

Continuous heparin infusionIntermittent heparin infusionduring catheter ablation

Outcome Measures

Primary Outcomes (1)

  • therapeutic ACT retention rate during procedure

    2 years

Study Arms (2)

Continuous heparin infusion group

ACTIVE COMPARATOR

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

Drug: Continuous heparin infusion

Intermittent heparin infusion group

ACTIVE COMPARATOR

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.

Drug: Intermittent heparin infusion

Interventions

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

Continuous 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.

Intermittent heparin infusion group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Atrial Fibrillation, Radiofrequency catheter ablation scheduled

You may not qualify if:

  • Clinical trial denied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul st. mary's hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Yong Seog Oh, MD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2013

First Posted

September 5, 2013

Study Start

December 1, 2012

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations