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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: ThermoCool® SF NAV Catheter Device: ThermoCool® catheter Not Applicable

Detailed Description:
Final report

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Atrial Pressure Electrophysiology Pilot Study: Comparison of High vs. Low Flow Catheters During Radiofrequency Catheter Ablation (RFCA) for Atrial Fibrillation (AF).
Study Start Date : May 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01845974


Locations
United States, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Scott Martin Miller, MD
Biosense Webster, Inc.
Investigators
Principal Investigator: Scott Miller, MD Advocate Lutheran General Hospital

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
First Posted: May 3, 2013    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Scott Martin Miller, MD, Advocate Health Care:
Radiofrequency Catheter Ablation
Atrial Fibrillation

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