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Atrial Pressure Electrophysiology Pilot Study (APES)

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ClinicalTrials.gov Identifier: NCT01845974
Recruitment Status : Terminated (Interim evaluation of data after internal safety report from sponsor.)
First Posted : May 3, 2013
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Scott Martin Miller, MD, Advocate Health Care

May 1, 2013
May 3, 2013
May 22, 2017
February 7, 2018
February 7, 2018
May 2013
December 2016   (Final data collection date for primary outcome measure)
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements [ Time Frame: Observation period is up to the 24 hours post procedure ]
The objective of this pilot study is to investigate the use of a lower flow catheter (ThermoCool® SF NAV Catheter, Biosense Webster, Inc. Diamond Bar, CA, eluting 8-15ml/minute during RF lesion delivery) vs. a higher flow catheter (ThermoCool® catheter, same manufacturer, eluting 17-30 ml/minute), Outcomes are measured by number of Participants with Hemodynamic, Electrolyte, and Electrophysiologic Derangements, is reported. This was measured as participants requiring electrolyte replacement, if the BP dropped below 100 mm in CICU or if participants sustained atrial tachyarrhythmias
Hemodynamic Changes [ Time Frame: up to 24 hours after procedure ]
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.
Complete list of historical versions of study NCT01845974 on ClinicalTrials.gov Archive Site
Not Provided
  • Electrophysiologic changes [ Time Frame: up to 24 hours after procedure ]
    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 ]
    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.
Not Provided
Electrolyte changes [ Time Frame: up to 24 hours after procedure ]
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.
 
Atrial Pressure Electrophysiology Pilot Study
Atrial Pressure Electrophysiology Pilot Study: Comparison of High vs. Low Flow Catheters During Radiofrequency Catheter Ablation (RFCA) for Atrial Fibrillation (AF).
This study examined data elements of hemodynamic, electrophysiologic and electrolyte trends comparing 2 different types of catheters used during a procedure to treat medication resistant atrial fibrillation-radiofrequency catheter ablation. A high flow catheter delivers a high volume of saline during the procedure. The low flow catheter delivers a low 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.
Final report
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Atrial Fibrillation
  • Device: ThermoCool® SF NAV 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® 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.
  • 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.
    Intervention: 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.
    Intervention: Device: ThermoCool® catheter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
40
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Drug resistant paroxysmal AF
  • ≥ 18 years old

Exclusion Criteria:

  • Left atrial thrombus on TEE
  • Patients unable to provide informed consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01845974
#5387
Yes
Not Provided
Plan to Share IPD: No
Scott Martin Miller, MD, Advocate Health Care
Scott Martin Miller, MD
Biosense Webster, Inc.
Principal Investigator: Scott Miller, MD Advocate Lutheran General Hospital
Advocate Health Care
January 2018

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