Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660, United States
NCT Number: NCT02028143
Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Kingsport, Tennessee, 37660, United States
Atrial fibrillation is the most common rhythm disturbance affecting the human population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: during procedure
to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system
Time frame: during procedure
Evaluate the time required to obtain electrical isolation of PV system
Time frame: during procedure
evaluate the use of ultrasound catheter for adverse events such as cardiac perforation, emboli or fistula formation
Gregory Jones
Other
Acronym: ICE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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