Endocardial Mapping with the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
Status: Recruiting
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
• Subject is 18 to 80 years of age
• Patient scheduled for standard of care AF ablation
• Subject is able to provide written informed consent
• Subject is able and willing to complete all study procedures
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: 150
Treatments
Experimental: Phase 1- Mapping Only
For Phase 1, the goal is to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
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 chronic efficacy of the CoreMap EP Mapping System.
Experimental: Phase 3 - Map Guided Ablation
For Phase 3, the goal is the evaluation of a CoreMap guided tailored ablation strategy and to demonstrate chronic safety and effectiveness in de novo PerAF patients with the CoreMap EP Mapping System.
Related Therapeutic Areas
Sponsors
Leads: CoreMap Inc.