NCT06529978 · CoreMap Inc.
Endocardial Mapping With the CoreMap EP Mapping System
(INvENI)
What this study is about
This is a global, multi-site, forward-looking, feasibility study.
View original scientific description
This is a global, multi-site, prospective, feasibility study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Naples, Florida
- Burlington, Vermont
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations