One More Magnetic Resonance Imaging



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:3/2/2017
Start Date:December 2013
End Date:January 2017

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The objective of this study is to utilize delayed enhanced cardiac magnetic resonance
imaging to assess the success of pulmonary vein isolation after cryoablation of paroxysmal
atrial fibrillation. The primary hypothesis is that cardiac magnetic resonance imaging will
be able to visualize changes in left atrial tissue characteristics caused by cryoablation
used to treat paroxysmal atrial fibrillation.

Atrial fibrillation (AF) is the most common arrhythmia in the world, affecting 1-2% of the
general population and 10% of people older than 80 years old. Medical therapy is only
partially effective at treatment of symptoms of atrial fibrillation and ablation procedures
have been developed that offer a potential curative approach to treatment of the symptoms of
atrial fibrillation. Prior to an ablation procedure, it is standard of care to perform
imaging (either contrast cardiac computed tomography or cardiac magnetic resonance (CMR)
imaging) to determine the size and orientation of the pulmonary veins, the presence or
absence of left atrial thrombus and the size and volume of the left atrium. Cardiac magnetic
resonance imaging has the advantage of high spatial resolution without additional radiation
exposure. There are some additional features of CMR that make it potentially even more
useful for patients undergoing an ablation procedure for treatment of atrial fibrillation.
One main advantage involves the use of delayed-enhancement MRI (DE-MRI) to characterize the
tissue of the left atrium to visualize the presence of absence of scars. Prior studies have
demonstrated the ability of CMR to visualize radiofrequency-induced scar in the left atrial
wall after atrial fibrillation ablation. These studies have postulated that CMR could be
utilized to determine the success rates of atrial fibrillation ablation. However, there has
been significant variability between published studies looking at CMR post radiofrequency
ablation, which for many years was the only type of ablation procedure available to treat
atrial fibrillation. Some studies demonstrate a correlation between DE-MRI and ablation
lesions, while others do not report such a correlation. Furthermore, no study to date has
been designed to examine cryoablation specifically. Cryoablation is alternative method of
performing an ablation procedure that utilizes a freezing balloon to make a circumferential
lesion around the atrum of the pulmonary vein, as opposed to radiofrequency ablation which
uses a catheter to create the same pattern of lesions around the pulmonary vein utilizing a
4mm catheter that generates heat as a byproduct of radiofrequency energy. Using DE-MRI to
analyze injury and scar after cryoablation would be a novel application of this imaging
modality.

There are several reasons why lesions produced with cryoablation procedures may offer better
visualization on DE-MRI as compared to radiofrequency ablation. First, the circumferential
lesion generated by cryoablation is created utilizing a uniform distribution of energy in a
simultaneous fashion to the entire pulmonary vein antrum. In contrast, lesions created by
radiofrequency ablation are produced sequentially and each lesion has variable contact with
the myocardium and therefore variable energy delivery. As a consequence, lesions created
with radiofrequency ablation may not uniformly penetrate the myocardium, creating a
situation whereby contiguous lesions have variable depth. This may explain the heterogeneity
of scar visualization on DE-MRI in earlier studies. Furthermore, despite the advantages and
accuracy of electroanatomical mapping, due to variations in tissue architecture in the
pulmonary vein antrum, there may be technical challenges in ensuring truly contiguous
lesions. Unfortunately, the non-contiguous nature of radiofrequency ablation lesions may not
be become evident until localized tissue edema has subsided and clinical evidence of
recurrent atrial fibrillation is observed several months after the procedure. Cryoablation
offers a theoretical advantage in this regard by producing near uniform tissue contact as
well as an ability to assess for gaps in tissue contact by injecting contrast dye under
fluoroscopic visualization during the period of pulmonary vein occlusion to demonstrate
areas of poor tissue contact where contrast dye escapes from the occluded pulmonary vein.
Another advantage is that the cryoballoon is in contact with a greater amount of myocardium
in the pulmonary vein antrum than the radiofrequency ablation catheter due to the larger
surface area of the 23 or 28mm diameter cryoballoon as compared to the 3.5 or 4mm diameter
radiofrequency ablation catheter. The smaller surface area of the radiofrequency ablation
lesions may be missed in the delayed enhancement sequences on MRI, which are acquired at a
greater slice thickness as compared with standard acquisition. Therefore, the cryoablation
lesions may be more likely to be visualized, as there is a greater probability that some
portion of the ablated myocardium will be present in a given imaging slice of delayed
enhanced atrial myocardium. Finally, the nature of cryoablation itself may cause less
inflammation in the short term in the atrial myocardium as compared to radiofrequency
ablation due to the fact that the tissue is frozen and not heated. The effect of this on
ability to visualize ablated tissue on DE-MRI is unknown, as none of the published studies
have examined cryoablation specifically.

Inclusion Criteria:

- Age > 18 years and < 80 years

- A diagnosis of symptomatic paroxysmal atrial fibrillation refractory to medical
therapy and planned to undergo a cryoablation procedure.

Exclusion Criteria:

- Unable or unwilling to undergo magnetic resonance imaging (including implanted metal
prosthesis, severe claustrophobia and inability to tolerate sedation)

- Previous atrial fibrillation ablation

- Patients who are not candidates for cryoablation procedure for treatment of atrial
fibrillation
We found this trial at
1
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Kansas City, Missouri 64111
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Kansas City, MO
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