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Completed

NCT Number: NCT02875730

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Cryoablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Sequence

Procedure

Cylindrical Navigator Preparatory Pulse Sequence

CMRI

Procedure

Cardiac Magnetic Resonance Imaging

Primary outcomes

  1. Blood Pool Corrected Signal Intensity

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

  2. Imaging Failure Rate

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

  3. Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme

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

Sponsors and collaborators

Lead sponsor

Aspire Foundation

Other

Registry information

Official study title

A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium

Acronym: LAMDE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2016
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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