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Prospective Study to Validate Ablation Parameters With MRI Based Scar for Left Atrial Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363307
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Ravi Ranjan, University of Utah

Brief Summary:

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Device: AF Ablation Device: MRI

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study to Validate Ablation Parameters With MRI Based Scar for Left Atrial Ablation
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : November 11, 2023
Estimated Study Completion Date : November 11, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Adult participants
Adult participants ages 18 and older with AF
Device: AF Ablation
Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT

Device: MRI
Adult participants will undergo a late gadolinium enhancement MRI of the left atrium three months post standard of care ablation




Primary Outcome Measures :
  1. Correlation of ablative force with scar formation, on a scale of 0 (no correlation) to 1 (total correlation) [ Time Frame: 3 months ]
  2. Correlation of ablative power with scar formation, on a scale of 0 (no correlation) to 1 (total correlation) [ Time Frame: 3 months ]
  3. Correlation of ablation time on scar formation, on a scale of 0 (no correlation) to 1 (total correlation) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in circumferential extent of the lesion around pulmonary veins after ablation as measured by scar area [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants ages 18 or older with paroxysmal or early persistent AF who will undergo their first ablation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363307


Contacts
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Contact: Ravi Ranjan, MD 801-587-5888 ravi.ranjan@hsc.utah.edu
Contact: Jonathan Gutierrez 801-581-5533 jonathan.gutierrez@utah.edu

Locations
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United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Ravi Ranjan, MD    801-587-5888    ravi.ranjan@hsc.utah.edu   
Sponsors and Collaborators
Ravi Ranjan
Biosense Webster, Inc.
Investigators
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Principal Investigator: Ravi Ranjan, MD University of Utah
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Responsible Party: Ravi Ranjan, Associate Professor, Cardiology, University of Utah
ClinicalTrials.gov Identifier: NCT04363307    
Other Study ID Numbers: IRB_00130480
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ravi Ranjan, University of Utah:
Atrial fibrillation
Ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes