Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03786822

Run by

University of Texas Southwestern Medical Center

People needed

1

Starts

2015-06-01

Expected to finish

2016-12-20

Last updated by the study team

2018-12-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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