Atrial Pressure Electrophysiology Pilot Study (APES)

Wake Forest University (WFU)

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Device: ThermoCool® SF NAV Catheter; Device: ThermoCool® catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01845974

#5387

Details and patient eligibility

About

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.

Full description

Final report

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Drug resistant paroxysmal AF
• ≥ 18 years old

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Low Flow Catheter

Experimental group

Description:

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.

Treatment:

Device: ThermoCool® SF NAV Catheter

High Flow Catheter

Active Comparator group

Description:

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.

Treatment:

Device: ThermoCool® catheter