Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation
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.
Interventions
DEVICEBiosense 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.
PROCEDUREPulmonary vein isolation
PROCEDUREICE catheter placed through one of two existing 8F sheaths
Sponsors
Biosense Webster, Inc.
Gregory Jones
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 80 years * Recommended for radiofrequency ablation of nonvalvular atrial fibrillation
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| to assess number of lesions to obtain Electrical Isolation PV system | during procedure | Evaluate the time required to obtain electrical isolation of PV system |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety-Cardiac perforation, emboli, fistula formation | during procedure | evaluate the use of ultrasound catheter for adverse events such as cardiac perforation, emboli or fistula formation |
Countries
United States
Outcome results
None listed