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One More Magnetic Resonance Imaging (OMM)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed Enhanced Cardiac Magnetic Resonance Imaging
Cryoablation
Sponsored by
Saint Luke's Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years and < 80 years
  • A diagnosis of symptomatic paroxysmal atrial fibrillation refractory to medical therapy and planned to undergo a cryoablation procedure.

Exclusion Criteria:

  • Unable or unwilling to undergo magnetic resonance imaging (including implanted metal prosthesis, severe claustrophobia and inability to tolerate sedation)
  • Previous atrial fibrillation ablation
  • Patients who are not candidates for cryoablation procedure for treatment of atrial fibrillation

Sites / Locations

  • Saint Luke's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repeat Cardiac MRI Post Cryoablation

Arm Description

All subjects in this study receive a follow up delayed enhanced cardiac MRI 2-6 weeks after they undergo a cryoablation procedure.

Outcomes

Primary Outcome Measures

Visualization of late gadolinium enhancement in the pulmonary veins on cardiac MRI
The signal intensity of late gadolinium enhancement in the pulmonary vein region as measured on a cardiac MRI, in comparison to the signal intensity of the blood pool

Secondary Outcome Measures

Recurrence of atrial fibrillation
Electrocardiogram recording of atrial fibrillation of at least 30 seconds in duration recorded on a 30 day event montor performed 3-6 months post ablation

Full Information

First Posted
November 10, 2014
Last Updated
February 28, 2017
Sponsor
Saint Luke's Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02293070
Brief Title
One More Magnetic Resonance Imaging
Acronym
OMM
Official Title
One More Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Luke's Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to utilize delayed enhanced cardiac magnetic resonance imaging to assess the success of pulmonary vein isolation after cryoablation of paroxysmal atrial fibrillation. The primary hypothesis is that cardiac magnetic resonance imaging will be able to visualize changes in left atrial tissue characteristics caused by cryoablation used to treat paroxysmal atrial fibrillation.
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia in the world, affecting 1-2% of the general population and 10% of people older than 80 years old. Medical therapy is only partially effective at treatment of symptoms of atrial fibrillation and ablation procedures have been developed that offer a potential curative approach to treatment of the symptoms of atrial fibrillation. Prior to an ablation procedure, it is standard of care to perform imaging (either contrast cardiac computed tomography or cardiac magnetic resonance (CMR) imaging) to determine the size and orientation of the pulmonary veins, the presence or absence of left atrial thrombus and the size and volume of the left atrium. Cardiac magnetic resonance imaging has the advantage of high spatial resolution without additional radiation exposure. There are some additional features of CMR that make it potentially even more useful for patients undergoing an ablation procedure for treatment of atrial fibrillation. One main advantage involves the use of delayed-enhancement MRI (DE-MRI) to characterize the tissue of the left atrium to visualize the presence of absence of scars. Prior studies have demonstrated the ability of CMR to visualize radiofrequency-induced scar in the left atrial wall after atrial fibrillation ablation. These studies have postulated that CMR could be utilized to determine the success rates of atrial fibrillation ablation. However, there has been significant variability between published studies looking at CMR post radiofrequency ablation, which for many years was the only type of ablation procedure available to treat atrial fibrillation. Some studies demonstrate a correlation between DE-MRI and ablation lesions, while others do not report such a correlation. Furthermore, no study to date has been designed to examine cryoablation specifically. Cryoablation is alternative method of performing an ablation procedure that utilizes a freezing balloon to make a circumferential lesion around the atrum of the pulmonary vein, as opposed to radiofrequency ablation which uses a catheter to create the same pattern of lesions around the pulmonary vein utilizing a 4mm catheter that generates heat as a byproduct of radiofrequency energy. Using DE-MRI to analyze injury and scar after cryoablation would be a novel application of this imaging modality. There are several reasons why lesions produced with cryoablation procedures may offer better visualization on DE-MRI as compared to radiofrequency ablation. First, the circumferential lesion generated by cryoablation is created utilizing a uniform distribution of energy in a simultaneous fashion to the entire pulmonary vein antrum. In contrast, lesions created by radiofrequency ablation are produced sequentially and each lesion has variable contact with the myocardium and therefore variable energy delivery. As a consequence, lesions created with radiofrequency ablation may not uniformly penetrate the myocardium, creating a situation whereby contiguous lesions have variable depth. This may explain the heterogeneity of scar visualization on DE-MRI in earlier studies. Furthermore, despite the advantages and accuracy of electroanatomical mapping, due to variations in tissue architecture in the pulmonary vein antrum, there may be technical challenges in ensuring truly contiguous lesions. Unfortunately, the non-contiguous nature of radiofrequency ablation lesions may not be become evident until localized tissue edema has subsided and clinical evidence of recurrent atrial fibrillation is observed several months after the procedure. Cryoablation offers a theoretical advantage in this regard by producing near uniform tissue contact as well as an ability to assess for gaps in tissue contact by injecting contrast dye under fluoroscopic visualization during the period of pulmonary vein occlusion to demonstrate areas of poor tissue contact where contrast dye escapes from the occluded pulmonary vein. Another advantage is that the cryoballoon is in contact with a greater amount of myocardium in the pulmonary vein antrum than the radiofrequency ablation catheter due to the larger surface area of the 23 or 28mm diameter cryoballoon as compared to the 3.5 or 4mm diameter radiofrequency ablation catheter. The smaller surface area of the radiofrequency ablation lesions may be missed in the delayed enhancement sequences on MRI, which are acquired at a greater slice thickness as compared with standard acquisition. Therefore, the cryoablation lesions may be more likely to be visualized, as there is a greater probability that some portion of the ablated myocardium will be present in a given imaging slice of delayed enhanced atrial myocardium. Finally, the nature of cryoablation itself may cause less inflammation in the short term in the atrial myocardium as compared to radiofrequency ablation due to the fact that the tissue is frozen and not heated. The effect of this on ability to visualize ablated tissue on DE-MRI is unknown, as none of the published studies have examined cryoablation specifically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repeat Cardiac MRI Post Cryoablation
Arm Type
Experimental
Arm Description
All subjects in this study receive a follow up delayed enhanced cardiac MRI 2-6 weeks after they undergo a cryoablation procedure.
Intervention Type
Other
Intervention Name(s)
Delayed Enhanced Cardiac Magnetic Resonance Imaging
Other Intervention Name(s)
Delayed Enhanced Cardiac MRI
Intervention Description
Subjects in this study get a Delayed Enhanced Cardiac Magnetic Resonance Imaging 2-6 weeks after they undergo cryoablation for atrial fibrillation. This MRI is compared to the pre-procedure cardiac MRI to determine if it possible to visualize the cryoablation lesions.
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Cryoballoon Ablation
Intervention Description
All subjects in this study undergo a cryoballoon ablation procedure to achieve pulmonary vein isolation for the purposes of treatment of atrial fibrillation
Primary Outcome Measure Information:
Title
Visualization of late gadolinium enhancement in the pulmonary veins on cardiac MRI
Description
The signal intensity of late gadolinium enhancement in the pulmonary vein region as measured on a cardiac MRI, in comparison to the signal intensity of the blood pool
Time Frame
2-6 weeks after ablation
Secondary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Description
Electrocardiogram recording of atrial fibrillation of at least 30 seconds in duration recorded on a 30 day event montor performed 3-6 months post ablation
Time Frame
3-6 months after ablation

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: Age > 18 years and < 80 years A diagnosis of symptomatic paroxysmal atrial fibrillation refractory to medical therapy and planned to undergo a cryoablation procedure. Exclusion Criteria: Unable or unwilling to undergo magnetic resonance imaging (including implanted metal prosthesis, severe claustrophobia and inability to tolerate sedation) Previous atrial fibrillation ablation Patients who are not candidates for cryoablation procedure for treatment of atrial fibrillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjaya Gupta, MD
Organizational Affiliation
Saint Luke's Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

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One More Magnetic Resonance Imaging

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