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

This study is currently recruiting participants.
Verified January 2014 by Seoul St. Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01935557
First received: September 1, 2013
Last updated: January 6, 2014
Last verified: January 2014

September 1, 2013
January 6, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
therapeutic ACT retention rate during procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01935557 on ClinicalTrials.gov Archive Site
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Not Provided
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Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coagulation; Intravascular
  • Drug: Continuous heparin infusion
    continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
    Other Name: Continuous heparin infusion
  • 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.
    Other Name: Intermittent heparin infusion
  • Active Comparator: Continuous heparin infusion group
    continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
    Intervention: Drug: Continuous heparin infusion
  • Active Comparator: 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.
    Intervention: Drug: Intermittent heparin infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria:

  • Clinical trial denied
Both
Not Provided
No
Contact: Yong Seog Oh, MD 82-2-2258-1141 oys@catholic.ac.kr
Korea, Republic of
 
NCT01935557
COHERE
No
Yong Seog Oh, Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
Not Provided
Principal Investigator: Yong Seog Oh, MD Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP