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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
  Purpose

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.


Condition Intervention Phase
Coagulation; Intravascular Drug: Continuous heparin infusion Drug: Intermittent heparin infusion Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Yong Seog Oh, Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • therapeutic ACT retention rate during procedure [ Time Frame: 2 years ]

Enrollment: 296
Study Start Date: December 2012
Study Completion Date: December 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous heparin infusion group
continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
Drug: Continuous heparin infusion
continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
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.
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria:

  • Clinical trial denied
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935557


Locations
Korea, Republic of
Seoul st. mary's hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yong Seog Oh
Investigators
Principal Investigator: Yong Seog Oh, MD Seoul St. Mary's Hospital
  More Information

Responsible Party: Yong Seog Oh, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01935557     History of Changes
Other Study ID Numbers: COHERE
First Submitted: September 1, 2013
First Posted: September 5, 2013
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by Yong Seog Oh, Seoul St. Mary's Hospital:
Continuous heparin infusion
Intermittent heparin infusion
during catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action