Back to resultsA Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement (LAMDE)
Primary Purpose
Atrial Fibrillation, Cryoablation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pulse Sequence
CMRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Saint Luke's Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CMRI Pulse Sequence
Arm 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.
Outcomes
Primary Outcome Measures
Blood Pool Corrected Signal Intensity
Imaging Failure Rate
Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875730
Brief Title
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement
Acronym
LAMDE
Official Title
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
March 6, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aspire Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cryoablation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CMRI Pulse Sequence
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Pulse Sequence
Intervention Description
Cylindrical Navigator Preparatory Pulse Sequence
Intervention Type
Procedure
Intervention Name(s)
CMRI
Intervention Description
Cardiac Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
Blood Pool Corrected Signal Intensity
Time Frame
Through study completion, an average of 1 year
Title
Imaging Failure Rate
Time Frame
Through study completion, an average of 1 year
Title
Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Saint Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement
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