CoreMap EP Mapping System for Persistent Atrial Fibrillation
This study is testing a new medical device called the CoreMap EP Mapping System for people with persistent atrial fibrillation (AF), a type of irregular heartbeat. The CoreMap system helps doctors understand your heart's electrical activity (endocardial mapping) and guide a procedure called ablation to correct the irregular rhythm. The study aims to see how safe and effective the CoreMap system is. For some participants, it will compare the CoreMap system to standard care. To join, you must be between 18 and 80 years old and have persistent or long-standing persistent AF. The study will look at how well the treatment works after 6 and 12 months. The study is currently recruiting 245 participants.
- Study design
- This is a global, multi-site study that will enroll 245 participants. It has three phases, with some phases comparing the CoreMap system to a control group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be checked at 7 days, and then again at 6 and 12 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Endocardial Mapping With the CoreMap EP Mapping System
At a glance
Conditions
NCT06529978
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Na Homolce Hospital
Praha Klanovice, Czechiano site contact published
Recruiting
NCH Downtown Baker Hospital
Naples, Floridano site contact published
Enrolling by invitation
University of Vermont Medical Center
Burlington, Vermontno site contact published
Enrolling by invitation
Virginia Commonwealth University (VCU)
Richmond, Virginiano site contact published
Enrolling by invitation
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sarah Kalil · STUDY_DIRECTOR · CoreMap Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phases 1 and Phase 2 Primary Endpoint:7 days
Incidence of study device related serious adverse events within seven (7) days of the study procedure.
- Phase 2 and Phase 3 Primary Effectiveness Endpoint:6 and 12 months
Freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through a 12-month follow-up and excluding a 90-day blanking period.