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

Atrial Fibrillation Clinical Trial

— ICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028143
• Other study ID #: ICE
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: April 23, 2018
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: April 2018
• Source: Wellmont CVA Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 to 80 years

• Recommended for radiofrequency ablation of nonvalvular atrial fibrillation

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Biosense Webster irrigated tip catheter
The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.
• Biosense Webster irrigated tip catheter
Group 1 will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.

Procedure:
• Pulmonary vein isolation

• ICE catheter placed through one of two existing 8F sheaths

Locations

Country	Name	City	State
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Gregory Jones	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety-Cardiac perforation, emboli, fistula formation	evaluate the use of ultrasound catheter for adverse events such as cardiac perforation, emboli or fistula formation	during procedure
Primary	number of lesions requiring ablation to obtain Electrical Isolation PV System	to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system	during procedure
Secondary	to assess number of lesions to obtain Electrical Isolation PV system	Evaluate the time required to obtain electrical isolation of PV system	during procedure