Study Summary
This trial tests a new, tailored way of performing ablation for atrial fibrillation against the standard method.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 12 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Anatomical
1 of 2
Tailored
1 of 2
Active Control
Experimental Treatment
377 Total Participants · 2 Treatment Groups
Primary Treatment: Dispersion ablation + PVI · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Seitz, Julien, Clément Bars, Guillaume Théodore, Sylvain Beurtheret, Nicolas Lellouche, Michel Bremondy, Ange Ferracci, et al.. 2017. “AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2016.10.065.
- Seitz, Julien, Clément Bars, Guillaume Théodore, Sylvain Beurtheret, Nicolas Lellouche, Michel Bremondy, Ange Ferracci, et al.. 2017. “AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2016.10.065.
- Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.
- Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.
- 2021. "Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04702451.
Frequently Asked Questions
What is the scope of individuals participating in this investigation?
"To move forward with this research project, 374 suitable volunteers are required. Washington University in Saint Louis, Missouri and Kansas City Heart Rhythm Institute in Overland Park, Kansas are two of the many sites where participants may enroll." - Anonymous Online Contributor
Are there any available positions in this trial that participants can fill?
"Confirmed. The information available on clinicaltrials.gov affirms that this medical experiment is still seeking participants, as it was first posted on February 12th 2021 and updated lastly on May 12th 2022. 374 individuals will be recruited from 9 distinct sites for the study's duration." - Anonymous Online Contributor
How many centers are currently managing this experiment?
"Nine locations have opened recruitment for this trial, such as Washington University in Saint Louis, Kansas City Heart Rhythm Institute in Overland Park, and Grandview Medical Center in Birmingham. Additional sites are also available." - Anonymous Online Contributor