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: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

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?

Number of groups / cohorts

1

Cohorts and Interventions

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

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)	3 months
Correlation of ablative power with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)	3 months
Correlation of ablation time on scar formation, on a scale of 0 (no correlation) to 1 (total correlation)	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	3 months

Collaborators and Investigators

• Sponsor: Ravi Ranjan
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Ravi Ranjan, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IRB_00130480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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