Atrial Pressure Electrophysiology Pilot Study

Atrial Fibrillation Clinical Trial

— APES  

Official title:

Atrial Pressure Electrophysiology Pilot Study: Comparison of High vs. Low Flow Catheters During Radiofrequency Catheter Ablation (RFCA) for Atrial Fibrillation (AF).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01845974
• Other study ID #: #5387
• Status: Terminated
• Phase: N/A
• First received: May 1, 2013
• Last updated: January 9, 2018
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Final report

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Drug resistant paroxysmal AF

• = 18 years old

Exclusion Criteria:

• Left atrial thrombus on TEE

• Patients unable to provide informed consent

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Scott Martin Miller, MD	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. Epub 2006 Jun 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Observation period is up to the 24 hours post procedure