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

The University of Texas System (UT)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Cryoballoon Pulmonary Vein Isolation - PVI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03786822

STU 042013-074

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Non-fluoroscopic Cryoballoon PVI

Experimental group

Description:

1. Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform. 2. Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks. 3. Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.

Treatment:

Procedure: Cryoballoon Pulmonary Vein Isolation - PVI

Fluoroscopic Cryoballoon PVI

Active Comparator group

Description:

Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography

Treatment:

Procedure: Cryoballoon Pulmonary Vein Isolation - PVI