Atrial Pressure Electrophysiology Pilot Study (APES)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ThermoCool® SF NAV Catheter
ThermoCool® catheter
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring Radiofrequency Catheter Ablation, Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Drug resistant paroxysmal AF
- ≥ 18 years old
Exclusion Criteria:
- Left atrial thrombus on TEE
- Patients unable to provide informed consent
Sites / Locations
- Advocate Lutheran General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low Flow Catheter
High Flow Catheter
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01845974
First Posted
May 1, 2013
Last Updated
January 9, 2018
Sponsor
Scott Martin Miller, MD
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01845974
Brief Title
Atrial Pressure Electrophysiology Pilot Study
Acronym
APES
Official Title
Atrial Pressure Electrophysiology Pilot Study: Comparison of High vs. Low Flow Catheters During Radiofrequency Catheter Ablation (RFCA) for Atrial Fibrillation (AF).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Interim evaluation of data after internal safety report from sponsor.
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Scott Martin Miller, MD
Collaborators
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Final report
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Radiofrequency Catheter Ablation, Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Flow Catheter
Arm Type
Experimental
Arm Description
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.
Arm Title
High Flow Catheter
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
ThermoCool® SF NAV Catheter
Intervention Description
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 Type
Device
Intervention Name(s)
ThermoCool® catheter
Intervention Description
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 Measure Information:
Title
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
Description
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
Time Frame
Observation period is up to the 24 hours post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Drug resistant paroxysmal AF
≥ 18 years old
Exclusion Criteria:
Left atrial thrombus on TEE
Patients unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Miller, MD
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16832250
Citation
Kiraly LN, Differding JA, Enomoto TM, Sawai RS, Muller PJ, Diggs B, Tieu BH, Englehart MS, Underwood S, Wiesberg TT, Schreiber MA. Resuscitation with normal saline (NS) vs. lactated ringers (LR) modulates hypercoagulability and leads to increased blood loss in an uncontrolled hemorrhagic shock swine model. J Trauma. 2006 Jul;61(1):57-64; discussion 64-5. doi: 10.1097/01.ta.0000220373.29743.69.
Results Reference
background
PubMed Identifier
9134280
Citation
Antoniou A, Milonas D, Kanakakis J, Rokas S, Sideris DA. Contraction-excitation feedback in human atrial fibrillation. Clin Cardiol. 1997 May;20(5):473-6. doi: 10.1002/clc.4960200514.
Results Reference
background
PubMed Identifier
16798819
Citation
Ninio DM, Saint DA. Passive pericardial constraint protects against stretch-induced vulnerability to atrial fibrillation in rabbits. Am J Physiol Heart Circ Physiol. 2006 Nov;291(5):H2547-9. doi: 10.1152/ajpheart.01248.2005. Epub 2006 Jun 23.
Results Reference
background
PubMed Identifier
8884512
Citation
Satoh T, Zipes DP. Unequal atrial stretch in dogs increases dispersion of refractoriness conducive to developing atrial fibrillation. J Cardiovasc Electrophysiol. 1996 Sep;7(9):833-42. doi: 10.1111/j.1540-8167.1996.tb00596.x.
Results Reference
background
PubMed Identifier
17540188
Citation
Gupta A, Lawrence AT, Krishnan K, Kavinsky CJ, Trohman RG. Current concepts in the mechanisms and management of drug-induced QT prolongation and torsade de pointes. Am Heart J. 2007 Jun;153(6):891-9. doi: 10.1016/j.ahj.2007.01.040.
Results Reference
background
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Atrial Pressure Electrophysiology Pilot Study
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