Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring cryoballoon, Atrial fibrillation, pulmonary vein isolation
Eligibility Criteria
Inclusion Criteria:
- Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
- Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.
Exclusion criteria:
- Planned use of radiofrequency cardiac ablation
- Presence of a cardiac implantable electronic device
- Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
- Patients with active systemic infections
- Patients with cryoglobulinemia
- Pregnant and/or breast-feeding females are excluded from this study.
Sites / Locations
- University of Texas Southwestern
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Non-fluoroscopic Cryoballoon PVI
Fluoroscopic Cryoballoon PVI
Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform. Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks. Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.
Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography