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

Aspire Foundation

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Cryoablation

Treatments: Procedure: CMRI; Procedure: Pulse Sequence

Study type: Interventional

Funder types: Other

Identifiers

NCT02875730

16-044

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CMRI Pulse Sequence

Experimental group

Description:

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.

Treatment:

Procedure: CMRI

Procedure: Pulse Sequence