An interventional study of Biosense Webster irrigated tip catheter and Biosense Webster irrigated tip catheter in Atrial Fibrillation, sponsored by Gregory Jones. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-24.
Sponsored by Gregory Jones · Not applicable, Interventional, and Treatment
Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation
Atrial fibrillation is the most common rhythm disturbance affecting the human population.
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 20 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Gregory Jones as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Procedure: ICE catheter placed through one of two existing 8F sheaths
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.
Device: Biosense Webster irrigated tip catheter · Procedure: Pulmonary vein isolation
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.
Also known as: 3.5mm 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.
Also known as: 3.5mm Biosense Webster irrigated tip catheter.
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
Time frame: during procedure
to assess number of lesions to obtain Electrical Isolation PV system
Evaluate the time required to obtain electrical isolation of PV system
Time frame: during procedure
Safety-Cardiac perforation, emboli, fistula formation
evaluate the use of ultrasound catheter for adverse events such as cardiac perforation, emboli or fistula formation
Time frame: during procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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