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

NCT04363307 | Completed FDA Device

• 1 other identifier: IRB_00130480
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Ablation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  3 months

Study Arms (1)

Adult participants

Adult participants ages 18 and older with AF

Device: AF Ablation; Device: MRI

Interventions

AF Ablation DEVICE

Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT

Adult participants

MRI DEVICE

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

Adult participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ravi Ranjan: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Ravi Ranjan, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Cardiology

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: May 14, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)