Atrial Fibrillation Clinical Trial
Official title:
CryobAllooN Targeting Atrial fibRosIs in Atrial Fibrillation
Pulmonary vein isolation (PVI) using cryoballoon ablation is a well-established procedure for
the treatment of atrial fibrillation (AF). However, the use of cryoballoon ablation in recent
clinical trials have been limited to PVI. As such, patients with paroxysmal AF have been the
main recipients of this procedure. In patients with persistent AF, or patients with
paroxysmal AF and significant AF substrate other than the pulmonary veins, the utility of
cryoballoon ablation is less straightforward. In such patients, the choices are to either use
cryoballoon ablation in a PVI-only approach or alternatively, use cryoballoon ablation for
PVI followed by the use of radiofrequency ablation for additional ablation and/or substrate
modification.
Substrate modification by targeting left atrial fibrosis detected on delayed enhancement
magnetic resonance imaging (DE-MRI) is an increasingly popular approach with growing data
showing its utility to decrease the risk of recurrence. The ability to use cryoballoon
ablation for fibrosis based ablation in addition to PVI will therefore provide a significant
advantage.
This study will evaluate feasibility and the outcome of targeted ablation of left atrial
fibrosis detected on DE-MRI in addition to pulmonary vein isolation using the Arctic Front
Advance Cryoballoon Catheter.
This is a single center open-label pilot study to be performed at the University of Utah
Hospital. Patients that are referred for first time ablation of paroxysmal or persistent
atrial fibrillation (AF) will be considered to be enrolled in the study. An electrocardiogram
(ECG) will be performed at the time of the first clinic visit with the documentation of the
rhythm. All patients will be started on an oral anticoagulation (either a novel
anticoagulation agent or warfarin with a targeted international normalized ratio (INR) of
2-3). All patients will have a basic metabolic panel, complete blood count, prothrombin
time/INR, thyroid-stimulating hormone, and a chest x-ray at the time of the first clinic
visit. Women of childbearing potential will have a β-human chorionic gonadotropin test to
rule out pregnancy. Within a month prior to the planned ablation, all patients will undergo a
DE-MRI to assess pulmonary vein anatomy, fibrosis burden and distribution, and left
ventricular function.
All patients will undergo a transesophageal echocardiogram immediately prior to the ablation
procedure to rule out thrombus within the left atrial appendage. If thrombus is detected, the
procedure will be postponed. AF ablation procedure will consist of pulmonary vein isolation
using the Medtronic Arctic Front Advance Cryoballoon Catheter. Following PVI, additional
lesions will be placed targeting areas of fibrosis by further manipulation of the catheter
from its position within pulmonary vein.
Following ablation, all patients will be observed for 24 hours to assess immediate post
procedural complications. All patients will be continued on anticoagulation for at least two
months. Patients may be continued on oral anticoagulation beyond two months post-ablation if
they are determined to have a high stroke risk profile.
A DE-MRI will be performed on all patients within 24 hours of ablation to assess esophageal
thermal injury. Patients with severe esophageal enhancement will have a repeat DE-MRI within
24 hours. Patients with moderate enhancement will have a repeat DE-MRI within 1 week. All
patients with persistent esophageal enhancement on repeat DE-MRI will be referred for
esophagogastroduodenoscopy. All patients will be placed on a proton pump inhibitor for 1
month.
All patients will be discharged with a 60-day event monitor. Continuation of antiarrhythmic
medications will be at the discretion of the performing physician. Following the procedure, a
90-day blanking period will start. Following the blanking period, patients will be monitored
for one year for recurrence of AF. Recurrence of AF is defined as a detectable episode of AF,
atrial flutter, or atrial tachycardia lasting at least 30 seconds. AF recurrence will be
assessed by 30-day event monitors at 3, 6, and 12-months following the blanking period. A
chest x-ray will be performed in all patients at the time of their first follow up visit.
All patients will undergo a DE-MRI at 3 months at the time which ablation scar size and
burden, progression of left atrial fibrosis as well as presence of pulmonary vein stenosis
will be assessed.
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