Actively Recruiting
Endocardial Mapping With the CoreMap EP Mapping System
Led by CoreMap Inc. · Updated on 2026-03-11
245
Participants Needed
3
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a global, multi-site, prospective, feasibility study.
CONDITIONS
Official Title
Endocardial Mapping With the CoreMap EP Mapping System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persistent or long-standing persistent atrial fibrillation (PerAF), as decided by the investigator (Phase 1 & 2)
- Persistent atrial fibrillation with no prior AF ablation therapy (Phase 3)
- Age between 18 and 80 years
- Presence of AF-related symptoms and scheduled for standard of care AF ablation for PerAF or long-standing PerAF (Phase 2 or 3)
- Ability to provide written informed consent
- Willingness and ability to complete all study procedures
You will not qualify if you...
- Myocardial infarction, cardiac procedures, or confirmed thrombus on imaging within 3 months before enrollment
- Cardiac surgery or thromboembolic event (stroke) within 6 months before enrollment
- New York Heart Association (NYHA) class IV heart failure
- Left ventricular ejection fraction below 30%
- Left atrial diameter greater than 55mm (Phase 3)
- Carotid stenting or endarterectomy
- Atrial or ventricular septal closure or left atrial appendage closure
- Implanted permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator (loop recorders allowed)
- Intramural thrombus, tumor, or abnormalities preventing catheter use
- Unstable angina
- Prior mitral or tricuspid valve surgery or severe valvular disease
- Blood clotting or bleeding disorders
- Contraindication to systemic anticoagulation
- AF due to electrolyte imbalance, acute alcohol intoxication, or reversible/non-cardiac causes
- Body mass index over 40 kg/m2
- Severe pulmonary disease, pulmonary hypertension, or chronic respiratory condition
- Renal failure requiring dialysis or transplant
- Acute illness, active infection, or sepsis
- Active drug or alcohol dependency
- Hypertrophic cardiomyopathy or cardiac amyloidosis
- Cor pulmonale
- Any contraindication that may extend procedure time
- Pregnant or breastfeeding women or women not on reliable birth control
- Vulnerable populations
- Life expectancy under one year
- Study site or sponsor employees
- Enrollment in other studies interfering with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
NCH Downtown Baker Hospital
Naples, Florida, United States, 34102
Enrolling by Invitation
2
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Enrolling by Invitation
3
Na Homolce Hospital
Praha Klanovice, Czechia
Actively Recruiting
Research Team
J
Jim Foster, SysEng
CONTACT
S
Sarah Kalil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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