Prospective Study to Validate Ablation Parameters With MRI Based Scar for Left Atrial Ablation
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|ClinicalTrials.gov Identifier: NCT04363307|
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : July 7, 2020
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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Device: AF Ablation Device: MRI|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prospective Study to Validate Ablation Parameters With MRI Based Scar for Left Atrial Ablation|
|Actual Study Start Date :||May 14, 2020|
|Estimated Primary Completion Date :||November 11, 2023|
|Estimated Study Completion Date :||November 11, 2023|
Adult participants ages 18 and older with AF
Device: AF Ablation
Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT
Adult participants will undergo a late gadolinium enhancement MRI of the left atrium three months post standard of care ablation
- Correlation of ablative force with scar formation, on a scale of 0 (no correlation) to 1 (total correlation) [ Time Frame: 3 months ]
- Correlation of ablative power with scar formation, on a scale of 0 (no correlation) to 1 (total correlation) [ Time Frame: 3 months ]
- Correlation of ablation time on scar formation, on a scale of 0 (no correlation) to 1 (total correlation) [ Time Frame: 3 months ]
- Change in circumferential extent of the lesion around pulmonary veins after ablation as measured by scar area [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363307
|Contact: Ravi Ranjan, MDemail@example.com|
|Contact: Jonathan Gutierrezfirstname.lastname@example.org|
|United States, Utah|
|University of Utah Health Sciences Center||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Ravi Ranjan, MD 801-587-5888 email@example.com|
|Principal Investigator:||Ravi Ranjan, MD||University of Utah|