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

NCT ID: NCT04363307

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2023-07-31

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult participants

Adult participants ages 18 and older with AF

AF Ablation

Intervention Type: DEVICE

Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT

MRI

Intervention Type: DEVICE

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

Interventions

AF Ablation

Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT

Intervention Type: DEVICE

MRI

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Ravi Ranjan

OTHER

Sponsor Role: lead

Responsible Party

Ravi Ranjan

Associate Professor, Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ravi Ranjan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB_00130480

Identifier Type: -

Identifier Source: org_study_id