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

NCT04363307 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Ravi Ranjan

    lead OTHER

Principal Investigators

  • Ravi Ranjan, MD · University of Utah

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363307 on ClinicalTrials.gov