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

Aspire Foundation10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Cryoablation

Interventions

Pulse SequencePROCEDURE

Cylindrical Navigator Preparatory Pulse Sequence

CMRIPROCEDURE

Cardiac Magnetic Resonance Imaging

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Saint Luke's Health System

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Blood Pool Corrected Signal Intensity

Time frame: Through study completion, an average of 1 year

Imaging Failure Rate

Time frame: Through study completion, an average of 1 year

Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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