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Completed

NCT Number: 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AF Ablation

Device

Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT

MRI

Device

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

Primary outcomes

  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 outcomes

  1. Change in circumferential extent of the lesion around pulmonary veins after ablation as measured by scar area

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ravi Ranjan

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2020
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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