Trial record 13 of 96 for:    Open Studies | "Heparin"

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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • therapeutic ACT retention rate during procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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.
Other Name: 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.
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atrial Fibrillation, Radiofrequency catheter ablation scheduled

Exclusion Criteria:

  • Clinical trial denied
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935557

Contacts
Contact: Yong Seog Oh, MD 82-2-2258-1141 oys@catholic.ac.kr

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

No publications provided

Responsible Party: Yong Seog Oh, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01935557     History of Changes
Other Study ID Numbers: COHERE
Study First Received: September 1, 2013
Last Updated: January 6, 2014
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014