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

Sponsor

Aspire Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT02875730

Collaborator

(none)

Enrollment

Location

Arm

16.4

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Cryoablation	Procedure: Pulse Sequence Procedure: CMRI	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium

Actual Study Start Date :

Dec 13, 2016

Actual Primary Completion Date :

Mar 6, 2018

Actual Study Completion Date :

Apr 27, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Blood Pool Corrected Signal Intensity [Through study completion, an average of 1 year]
Imaging Failure Rate [Through study completion, an average of 1 year]
Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Luke's Health System	Kansas City	Missouri	United States	64111

Sponsors and Collaborators

Aspire Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aspire Foundation

ClinicalTrials.gov Identifier:

NCT02875730

Other Study ID Numbers:

16-044

First Posted:

Aug 23, 2016

Last Update Posted:

Jun 29, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Jun 29, 2018