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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01935557
First Posted: September 5, 2013
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital
September 1, 2013
September 5, 2013
April 14, 2016
December 2012
July 2015   (Final data collection date for primary outcome measure)
therapeutic ACT retention rate during procedure [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01935557 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
  • 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.
  • 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.
 
Completed
296
December 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria:

  • Clinical trial denied
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01935557
COHERE
No
Not Provided
Not Provided
Yong Seog Oh, Seoul St. Mary's Hospital
Yong Seog Oh
Not Provided
Principal Investigator: Yong Seog Oh, MD Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
April 2016

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