Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a global, multi-site, prospective, feasibility study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
• Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
• Subject is 18 to 80 years of age
• Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)
• Subject is able to provide written informed consent
• Subject is able and willing to complete all study procedures
Locations
United States
Florida
NCH Downtown Baker Hospital
ENROLLING_BY_INVITATION
Naples
Vermont
University of Vermont Medical Center
ENROLLING_BY_INVITATION
Burlington
Contact Information
Primary
Jim Foster, SysEng
jfoster@coremapmedical.com
6178723908
Backup
Sarah Kalil
skalil@coremapmedical.com
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 245
Treatments
Experimental: Phase 1- Mapping Only
For Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent AF (PerAF) and long-standing persistent AF and to demonstrate safety.
Experimental: Phase 2- Map Guided Ablation
The Phase 2 goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and effectiveness of the CoreMap EP Mapping System in patients with PerAF and long-standing persistent AF..
Experimental: Phase 3 - Map Guided Ablation
For Phase 3, the goal is to evaluate the safety and effectiveness of the CoreMap EP Mapping System's ability to identify spatially constrained AF drivers and guide ablation therapy in PerAF patients with no history of prior AF ablation therapy. This phase aims to demonstrate safety and effectiveness compared to a control arm.
Related Therapeutic Areas
Sponsors
Leads: CoreMap Inc.