Endocardial Mapping With the CoreMap EP Mapping System
Recruiting · NCT06529978 · Interventional (participants receive a specific treatment) · Lead sponsor: CoreMap Inc.
View the official record on ClinicalTrials.gov →Interventions studied
CoreMap EP Mapping System Map-Guided AblationCoreMap EP Mapping System Mapping
What this trial is about
This is a global, multi-site, prospective, feasibility study.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- Active drug or alcohol dependency
- Hypertrophic cardiomyopathy or cardiac amyloidosis
- Cor pulmonale
- Any contra-indication that may extend procedure time, at the discretion of the operator
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- Subject considered part of vulnerable population
- Life expectancy less than one year
- Employee of the study site or Sponsor
- Subjects who are currently enrolled in another study that would directly interfere with this study
Where it is running
4 locations listed across 3 US states.
- 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
- Na Homolce Hospital - Praha Klanovice, Czechia