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Atrial FibrillationOMMNCT02293070

One More Magnetic Resonance Imaging

A study testing Delayed Enhanced Cardiac Magnetic Resonance Imaging and Cryoablation in people with Atrial Fibrillation, run by Saint Luke's Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Delayed Enhanced Cardiac Magnetic Resonance Imaging and Cryoablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Dec 2013to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

Other trials in United States

About this study

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.

Read the 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.

Being tested
Delayed Enhanced Cardiac Magnetic Resonance Imaging, Cryoablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delayed Enhanced Cardiac Magnetic Resonance ImagingOther

    Also called Delayed Enhanced Cardiac MRI

    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.

  • CryoablationProcedure or surgery

    Also called Cryoballoon Ablation

    All subjects in this study undergo a cryoballoon ablation procedure to achieve pulmonary vein isolation for the purposes of treatment of atrial fibrillation

Study groups in NCT02293070
Study groupRoleWhat they receive
Repeat Cardiac MRI Post CryoablationExperimentalAll subjects in this study receive a follow up delayed enhanced cardiac MRI 2-6 weeks after they undergo a cryoablation procedure.
Receives: Other: Delayed Enhanced Cardiac Magnetic Resonance Imaging; Procedure: Cryoablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2-6 weeks after ablation

Secondary outcomes (1)
  1. 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

    Measured: 3-6 months after ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293070
Sponsor's protocol ID
13-104
Acronym
OMM
Status last verified
Feb 2017
First submitted
10 Nov 2014
Last updated
1 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Delayed Enhanced Cardiac Magnetic Resonance Imaging and Cryoablation in people with Atrial Fibrillation, run by Saint Luke's Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visualization of late gadolinium enhancement in the pulmonary veins on cardiac MRI (time frame: 2-6 weeks after ablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.

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One More Magnetic Resonance Imaging (NCT02293070) | AzTrials