Clinical trial NCT01845974: Atrial Pressure Electrophysiology Pilot Study
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
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Radiofrequency Catheter Ablation
Atrial Fibrillation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2013-05-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria:

* Drug resistant paroxysmal AF
* ≥ 18 years old

Exclusion Criteria:

* Left atrial thrombus on TEE
* Patients unable to provide informed consent

Primary outcomes:
measure: Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
timeFrame: Observation period is up to the 24 hours post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
affiliation: Advocate Lutheran General Hospital
name: Scott Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.