ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02028143
• Lead Sponsor: Gregory Jones

Brief Summary

Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation

Detailed Description

Atrial fibrillation is the most common rhythm disturbance affecting the human population.

1. Its prevalence increases with age and can be found in \>8% of humans over the age of eighty;

2. Radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a common therapy available to patients. It has been shown to be both efficacious and cost effective;

3. The standard approach to atrial fibrillation involves electrical isolation of the pulmonary veins (PVI) from the rest of the atrium chamber. This involves moving a 3.5mm tip ablation catheter point to point around the PV structures until an encircling ablation line is formed. This can be made difficult by not knowing if the tip is in good contact with the atrial tissue. In addition the esophagus is a posterior lying structure and injury to the esophagus by ablating the overlying tissue has been reported, at times fatal;

4. Currently, intracardiac imaging of the left atrium has FDA approval in the right atrial chamber. This leads to difficulty in visualizing tip tissue interface, and important left sided structures such as carina, ligaments, and esophagus. By placing the tip of the ICE catheter in the left atrium, enhanced visualization of the tip tissue interface may lead to more effective ablation points, fewer needed ablation points, and enhanced safety by avoiding placement over adjacent noncardiac structures.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2015-01
• Study Completion: 2016-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18 to 80 years
• Recommended for radiofrequency ablation of nonvalvular atrial fibrillation

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of lesions requiring ablation to obtain Electrical Isolation PV System	during procedure	to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system

Secondary Outcome Measures

Name	Time	Method
to assess number of lesions to obtain Electrical Isolation PV system	during procedure	Evaluate the time required to obtain electrical isolation of PV system

Trial Locations

Locations (1)

Wellmont CVA Heart Institute; 🇺🇸 Kingsport, Tennessee, United States