Atrial Pressure Electrophysiology Pilot Study

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: ThermoCool® catheter; Device: ThermoCool® SF NAV Catheter

• Registration Number: NCT01845974
• Lead Sponsor: Wake Forest University Health Sciences

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-05-22
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-09
• Results First Posted: 2018-02-07
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Drug resistant paroxysmal AF
• ≥ 18 years old

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Catheter	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.
Low Flow Catheter	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements	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

Trial Locations

Locations (1)

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States