Endocardial Mapping With the CoreMap EP Mapping System

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

This is a global, multi-site, prospective, feasibility study.

Key facts

Study ID

NCT06529978

Run by

CoreMap Inc.

People needed

245

Starts

2024-07-25

Expected to finish

2026-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any of the following within three months of enrollment:
• Myocardial infarction (MI)
• Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
• Confirmed thrombus on imaging
• Any of the following within six months of enrollment:
• Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
• Thromboembolic event (stroke)
• Any of the following cardiac conditions:
• New York Heart Association (NYHA) IV
• Left ventricular ejection fraction (LVEF) < 30%
• Left atrial diameter >55mm (anterioposterior) (Phase 3)
• Carotid stenting or endarterectomy
• Atrial or ventricular septal closure or left atrial appendage closure
• Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
• Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Unstable angina
• Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
• Moderate to severe mitral valve stenosis or other severe valvular disease
• Any blood clotting or bleeding abnormalities
• Contraindication to systemic anticoagulation
• AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
• Body mass index (BMI) > 40 kg/m2
• Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
• Renal failure requiring dialysis or transplant
• Acute illness, active systemic infection, or sepsis

Where it is running

• Na Homolce Hospital — Praha Klanovice, Czechia (enrolling)
• NCH Downtown Baker Hospital — Naples, Florida, United States
• University of Vermont Medical Center — Burlington, Vermont, United States
• Virginia Commonwealth University (VCU) — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.