Atrial Fibrillation Clinical Trial
— CANARI-AFOfficial title:
CryobAllooN Targeting Atrial fibRosIs in Atrial Fibrillation
NCT number | NCT03489096 |
Other study ID # | IRB_00109729 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2019 |
Est. completion date | October 2021 |
Verified date | July 2019 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2021 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Referred for cryoballoon ablation of paroxysmal or persistent atrial fibrillation - 18 years of age or older - Ability to give informed consent in accordance with University of Utah IRB guidelines Exclusion Criteria: - Previous ablation for atrial fibrillation or atypical atrial flutter - Contraindication to MRI contrast agent - Unquantifiable fibrosis or moderate to severe left-atrial fibrosis (= 20%) - Contraindication for chronic anticoagulation therapy - Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular disease within the last 2 months - Implanted cardiac device - Presence of left atrial thrombus - Contraindications to cryoballoon ablation including history of cryoglobulinemia, active systemic infection, and presence of one or more pulmonary vein stents - New York Heart Association (NYHA) class IV heart failure - Women who are currently pregnant or breast feeding or using unreliable contraceptive measures if premenopausal - Enrollment in another investigational trial - Untreated hyperthyroidism or hypothyroidism - Life expectancy < 12 months due to a terminal disease - Presence of phrenic nerve injury at baseline elicited by hemidiaphragmatic paralysis on pre-ablation chest x-ray |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Medtronic |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of Atrial Fibrillation | Recurrence of atrial fibrillation will be defined by detection of an episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds during any of the study follow-up periods up to one year post-ablation. | 12 Months | |
Secondary | Recurrence of Atrial Fibrillation Stratified by Atrial Fibrillation Type | Recurrence of atrial fibrillation type will be compared to historical data of ablations targeting only pulmonary vein isolation | 12 Months |
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