Atrial Pressure Electrophysiology Pilot Study: Comparison of High vs. Low Flow Catheters During Radiofrequency Catheter Ablation (RFCA) for Atrial Fibrillation (AF).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
- Status
- Terminated
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Drug resistant paroxysmal AF
- •≥ 18 years old
Exclusion Criteria
- •Left atrial thrombus on TEE
- •Patients unable to provide informed consent
Outcomes
Primary Outcomes
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