A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement

Phase 4

Completed

• Conditions: Atrial Fibrillation; Cryoablation

• Registration Number: NCT02875730
• Lead Sponsor: Aspire Foundation

Brief Summary

This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Study Start: 2016-12-13
• Primary Completion: 2018-03-06
• Study Completion: 2018-04-27
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Saint Luke's Health System; 🇺🇸 Kansas City, Missouri, United States