Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06529978

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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