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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Pulmonary vein isolation; Device: Biosense Webster irrigated tip catheter; Device: Biosense Webster irrigated tip catheter; Procedure: ICE catheter placed through one of two existing 8F sheaths

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; The study arm 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.	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.; Other Names: 3.5mm Biosense Webster irrigated tip catheter.; Device: 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.; Other Names: 3.5mm Biosense Webster irrigated tip catheter.; Procedure: ICE catheter placed through one of two existing 8F sheaths
Active Comparator: Control arm; The control arm group 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; 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.; Other Names: 3.5mm Biosense Webster irrigated tip catheter.; Device: 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.; Other Names: 3.5mm Biosense Webster irrigated tip catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
to assess number of lesions to obtain Electrical Isolation PV system	Evaluate the time required to obtain electrical isolation of PV system	during procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gregory Jones
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Gregory Jones, MD, Wellmont CVA Heart Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ICE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No