A Study Comparing a High Flow of Saline Catheter to a Low Flow of Saline Catheter During RadioFrequency Ablation Study in Patients With Atrial Fibrillation (APES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Advocate Health Care
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Scott Martin Miller, MD, Advocate Health Care
ClinicalTrials.gov Identifier:
NCT01845974
First received: May 1, 2013
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

This study is examining data elements of hemodynamic, electrophysiologic and electrolyte trends comparing 2 different types of catheters used during a procedure to treat medication resistant atrial fibrillation- an irregular heart beat- called radiofrequency catheter ablation. A high flow catheter delivers a higher volume of saline during the procedure. The low flow catheter delivers a lower volume of saline during the procedure. The patient will be consented and randomized to one of the 2 groups using a computer generated randomization chart. Those that are put in the low flow catheter group will be considered the experimental group. All data will be collected before and after the procedure and each patient will act as their own control within each group. The hypothesis is that using a lower flow catheter will cause less hemodynamic, electrolyte, and electrophysiologic derangements resulting in better patient outcomes and fewer complications


Condition Intervention
Atrial Fibrillation
Device: ThermoCool® SF NAV Catheter
Device: ThermoCool® catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Atrial Pressure Electrophysiology Pilot Study: Comparison of High vs. Low Flow Catheters During Radiofrequency Catheter Ablation (RFCA) for Atrial Fibrillation (AF).

Resource links provided by NLM:


Further study details as provided by Advocate Health Care:

Primary Outcome Measures:
  • Hemodynamic Changes [ Time Frame: up to 24 hours after procedure ] [ Designated as safety issue: No ]
    This is a pilot study designed to discern if trends in hemodynamic changes related to relatively high as compared to relatively low cardiac volume loading can be demonstrated. If relevant trends are observed, we would anticipate performing a larger trial sufficiently powered to analyze these differences in a rigorous statistical manner.


Secondary Outcome Measures:
  • Electrophysiologic changes [ Time Frame: up to 24 hours after procedure ] [ Designated as safety issue: No ]
    This is a pilot study designed to discern if trends in electrophysiologic changes related to relatively high as compared to relatively low cardiac volume loading can be demonstrated. If relevant trends are observed, we would anticipate performing a larger trial sufficiently powered to analyze these differences in a rigorous statistical manner.

  • Echocardiographic changes [ Time Frame: up to 24 hours after procedure ] [ Designated as safety issue: No ]
    This is a pilot study designed to discern if trends in changes in cardiac chamber size and cardiac function related to relatively high as compared to relatively low cardiac volume loading can be demonstrated. If relevant trends are observed, we would anticipate performing a larger trial sufficiently powered to analyze these differences in a rigorous statistical manner.


Other Outcome Measures:
  • Electrolyte changes [ Time Frame: up to 24 hours after procedure ] [ Designated as safety issue: No ]
    This is a pilot study designed to discern if trends in electrolyte changes related to relatively high as compared to relatively low cardiac volume loading can be demonstrated. If relevant trends are observed, we would anticipate performing a larger trial sufficiently powered to analyze these differences in a rigorous statistical manner.


Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Flow Catheter
The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
Device: ThermoCool® SF NAV Catheter
Active Comparator: High Flow Catheter
The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
Device: ThermoCool® catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Drug resistant paroxysmal AF
  • ≥ 18 years old

Exclusion Criteria:

  • Left atrial thrombus on TEE
  • Patients unable to provide informed consent
  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: NCT01845974

Contacts
Contact: Scott Miller, MD 847.698.5500 scottmil@uic.edu
Contact: Gina Littlejohn, BSN 847.723.2099

Locations
United States, Illinois
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Scott M Miller, MD    847-698-5500    scottmil@uic.edu   
Principal Investigator: Scott M Miller, MD         
Sub-Investigator: Justin Weiner, MD         
Sub-Investigator: Marc Ovadia, MD         
Sub-Investigator: Stephen Smith, MD         
Sub-Investigator: Samuel Goldstein, MD         
Sponsors and Collaborators
Scott Martin Miller, MD
Biosense Webster, Inc.
Investigators
Principal Investigator: Scott Miller, MD Advocate Lutheran General Hospital
  More Information

Publications:
Responsible Party: Scott Martin Miller, MD, Advocate Medical Group, Advocate Health Care
ClinicalTrials.gov Identifier: NCT01845974     History of Changes
Other Study ID Numbers: #5387
Study First Received: May 1, 2013
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Advocate Health Care:
Radiofrequency Catheter Ablation
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014