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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04363307
• Other study ID #: IRB_00130480
• Status: Recruiting
• Start date: May 14, 2020
• Est. completion date: November 11, 2024

Study information

• Verified date: August 2023
• Source: University of Utah
• Contact: Ravi Ranjan, MD
• Phone: 801-587-5888
• Email: ravi.ranjan[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 11, 2024
• Est. primary completion date: November 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• AF Ablation
Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT
• MRI
Adult participants will undergo a late gadolinium enhancement MRI of the left atrium three months post standard of care ablation

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Ravi Ranjan	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of ablative force with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)		3 months
Primary	Correlation of ablative power with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)		3 months
Primary	Correlation of ablation time on scar formation, on a scale of 0 (no correlation) to 1 (total correlation)		3 months
Secondary	Change in circumferential extent of the lesion around pulmonary veins after ablation as measured by scar area		3 months