Atrial Fibrillation
Conditions
Keywords
cryoballoon, Atrial fibrillation, pulmonary vein isolation
Brief summary
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.
Detailed 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.
Interventions
PROCEDURECryoballoon Pulmonary Vein Isolation - PVI
A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.
Sponsors
Medtronic
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Subjects will be randomized in a 2:1 fashion
Intervention model description
Condition or Disease: Paroxysmal atrial fibrillation Procedure: Cryoballoon Pulmonary Vein Isolation
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation. | one year | change in the composite endpoint of total fluoroscopy time (min) |
| Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation. | one year | change in the composite endpoint of contrast (cc) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial fibrillation | one year | •recurrence of atrial fibrillation after 1 month blanking period measured by ECG event monitoring at 6 and 12 month follow up (time to first recurrence in months, total number of episodes, and total duration in hours) |
| Time to Cryoballoon Pulmonary Vein Isolation | one year | •cryoballoon procedure time (min) |
Countries
United States
Outcome results
None listed