Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/27/2018 |
| Start Date: | June 1, 2015 |
| End Date: | December 20, 2016 |
This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy
of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of
radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial
fibrillation.
One group of subjects will have the procedure performed with intracardiac echo maneuvers to
assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of
subjects who will receive the standard medical treatment with fluoroscopy and angiography.
of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of
radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial
fibrillation.
One group of subjects will have the procedure performed with intracardiac echo maneuvers to
assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of
subjects who will receive the standard medical treatment with fluoroscopy and angiography.
Surgical and catheter based technologies target triggers that initiate atrial fibrillation
located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency
energy or freezing is used to destroy the atrial tissue which propagate electrical impulses
into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a
patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and
efficacious under fluoroscopic guidance with contrast angiography. The objective of this
study is to identify methods to reduce radiation dose and radio opaque contrast use while
maintaining PVI efficacy and safety.
located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency
energy or freezing is used to destroy the atrial tissue which propagate electrical impulses
into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a
patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and
efficacious under fluoroscopic guidance with contrast angiography. The objective of this
study is to identify methods to reduce radiation dose and radio opaque contrast use while
maintaining PVI efficacy and safety.
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.
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