Back to resultsRandomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation (COHERE)
Primary Purpose
Coagulation; Intravascular
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Continuous heparin infusion
Intermittent heparin infusion
Sponsored by
About this trial
This is an interventional treatment trial for Coagulation; Intravascular focused on measuring Continuous heparin infusion, Intermittent heparin infusion, during catheter ablation
Eligibility Criteria
Inclusion Criteria:
- Atrial Fibrillation, Radiofrequency catheter ablation scheduled
Exclusion Criteria:
- Clinical trial denied
Sites / Locations
- Seoul st. mary's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continuous heparin infusion group
Intermittent heparin infusion group
Arm Description
continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
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.
Outcomes
Primary Outcome Measures
therapeutic ACT retention rate during procedure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01935557
Brief Title
Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
Acronym
COHERE
Official Title
Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulation; Intravascular
Keywords
Continuous heparin infusion, Intermittent heparin infusion, during catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous heparin infusion group
Arm Type
Active Comparator
Arm Description
continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
Arm Title
Intermittent heparin infusion group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Continuous heparin infusion
Intervention Description
continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
Intervention Type
Drug
Intervention Name(s)
Intermittent heparin infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
therapeutic ACT retention rate during procedure
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Atrial Fibrillation, Radiofrequency catheter ablation scheduled
Exclusion Criteria:
Clinical trial denied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul st. mary's hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29766891
Citation
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.
Results Reference
derived
Learn more about this trial
Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
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