- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04363307
Prospective Study to Validate Ablation Parameters With MRI Based Scar for Left Atrial Ablation
One of the goals of an ablation procedure is to create scarring of cardiac tissue. Not all ablations result in scar tissue. Advances in technology have improved scarring but ideal parameters that result in scar tissue are still not completely clear and there is great variability in the parameters used. Theoretically, intense ablation can always create scar tissue but is also likely to create more complications such as cardiac perforations. The investigator recently published another retrospective study looking at ablation parameters that reliably result in scar tissue but it had its limitations as it was retrospectively done.
This is a prospective study to validate the parameters that result in long term scarring. MRI has long been used to visualize ablation scar tissue. So in this study patients undergoing, initial left atrial ablation for atrial fibrillation as standard of care will undergo a 3 month post ablation MRI and that will be used to validate the ablation parameters.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A critical step to improve atrial fibrillation (AF) ablation broadly is to minimize interoperator variability. VISITAG SURPOINT calculated a marker tag index value by combining contact force, power setting, and duration of energy delivered. Use of VISITAG SURPOINT has accurately predicted sites of pulmonary vein reconnection and regional changes in late gadolinium enhancement (LGE) and T2 (edema) intensity 24 hours post ablation. Prospective use of the ablation index improves first pass pulmonary vein isolation and 1-year freedom from atrial tachyarrhythmias compared to conventional treatment.
There remains a paucity of data regarding if ablation guided by index values and VISITAG SURPOINT results in durable scar formation in humans in general and compared to conventional approaches. In addition, the relative contribution of the components of VISITAG SURPOINT impact scar formation in-vivo and across a broad diversity of atrial anatomies. Such data are critical in patients that present with various degrees of atrial myopathies, arrhythmia substrate, and anatomies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ravi Ranjan, MD
- Phone Number: 801-587-5888
- Email: ravi.ranjan@hsc.utah.edu
Study Contact Backup
- Name: Jonathan Gutierrez
- Phone Number: 801-581-5533
- Email: jonathan.gutierrez@utah.edu
Study Locations
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-
Utah
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Salt Lake City, Utah, United States, 84132
- Recruiting
- University of Utah Health Sciences Center
-
Contact:
- Ravi Ranjan, MD
- Phone Number: 801-587-5888
- Email: ravi.ranjan@hsc.utah.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Paroxysmal or early Persistent AF (continuous AF duration less than 3 months and CHADSVASC great than or equal to 2).
- First time ablation for AF
- Agreeable to a 3 month MRI
Exclusion Criteria:
- Claustrophobic (unable to undergo MRI)
- Having undergone prior left atrial ablation including AT or atypical flutter
- Metal implants that preclude getting an MRI
- eGFR < 30
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adult participants
Adult participants ages 18 and older with AF
|
Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT
Adult participants will undergo a late gadolinium enhancement MRI of the left atrium three months post standard of care ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of ablative force with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Time Frame: 3 months
|
3 months
|
Correlation of ablative power with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Time Frame: 3 months
|
3 months
|
Correlation of ablation time on scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in circumferential extent of the lesion around pulmonary veins after ablation as measured by scar area
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ravi Ranjan, MD, University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00130480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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