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

June 27, 2018 updated by: Aspire Foundation

A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CMRI 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.
Procedure: Pulse Sequence
Cylindrical Navigator Preparatory Pulse Sequence
Procedure: CMRI
Cardiac Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pool Corrected Signal Intensity
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Imaging Failure Rate
Time Frame: Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aspire Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2016

Primary Completion (Actual)

March 6, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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