Study Results
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View full resultsBasic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2013-05-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years old
Exclusion Criteria
* Patients unable to provide informed consent
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Scott Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Advocate Lutheran General Hospital
Locations
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Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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#5387
Identifier Type: -
Identifier Source: org_study_id
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