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Atrial Pressure Electrophysiology Pilot Study (APES)

This study has suspended participant recruitment.
(Interim evaluation of data after internal safety report from sponsor.)
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: January 6, 2016
Last verified: January 2016

May 1, 2013
January 6, 2016
May 2013
December 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01845974 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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.
Same as current
 
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 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
Preliminary interim Data in review.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.
 
Suspended
40
December 2017
December 2017   (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
Both
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
Not Provided
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 2016

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