Atrial Fibrillation, Cryoablation
Conditions
Brief summary
This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.
Interventions
PROCEDUREPulse Sequence
Cylindrical Navigator Preparatory Pulse Sequence
PROCEDURECMRI
Cardiac Magnetic Resonance Imaging
Sponsors
Aspire Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men or non-pregnant women * A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure * Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation.
Exclusion criteria
* Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits * Allergy to gadolinium-based contrast agent * Previous atrial fibrillation ablation * Renal dysfunction (estimated GFR \<60 mL/min/1.73m2) within 6 months * Unwilling to provide informed consent for this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pool Corrected Signal Intensity | Through study completion, an average of 1 year |
| Imaging Failure Rate | Through study completion, an average of 1 year |
| Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme | Through study completion, an average of 1 year |
Countries
United States
Outcome results
None listed