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

Phase 4

Completed

• Conditions: Atrial Fibrillation; Cryoablation
• Interventions: Procedure: Pulse Sequence; Procedure: CMRI

• 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

Arm && Interventions

Group	Intervention	Description
CMRI Pulse Sequence	Pulse Sequence	Patients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison.
CMRI Pulse Sequence	CMRI	Patients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison.

Primary Outcome Measures

Name	Time	Method
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
Blood Pool Corrected Signal Intensity	Through study completion, an average of 1 year

Trial Locations

Locations (1)

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