Endocardial Mapping With the CoreMap EP Mapping System

Last updated: March 9, 2026
Sponsor: CoreMap Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Cardiac Disease

Treatment

CoreMap EP Mapping System Map-Guided Ablation

CoreMap EP Mapping System Mapping

Clinical Study ID

NCT06529978
CD001
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has persistent or long-standing persistent AF, at the discretion of theinvestigator (Phase 1 & 2)

  2. Subject has PerAF with no history of prior AF ablation therapy (Phase 3)

  3. Subject is 18 to 80 years of age

  4. Subject has presence of AF-related symptoms and is scheduled for clinicallyindicated standard of care AF ablation to manage PerAF (Phase 2 or 3) orlong-standing PerAF (Phase 2)

  5. Subject is able to provide written informed consent

  6. Subject is able and willing to complete all study procedures

Exclusion

Exclusion Criteria:

  1. Any of the following within three months of enrollment:

  2. Myocardial infarction (MI)

  3. Any surgical or percutaneous cardiac procedure including coronary interventionand cardiac ablation

  4. Confirmed thrombus on imaging

  5. Any of the following within six months of enrollment:

  6. Cardiac surgery including coronary artery bypass grafting, ventriculotomy,atriotomy

  7. Thromboembolic event (stroke)

  8. Any of the following cardiac conditions:

  9. New York Heart Association (NYHA) IV

  10. Left ventricular ejection fraction (LVEF) < 30%

  11. Left atrial diameter >55mm (anterioposterior) (Phase 3)

  12. Carotid stenting or endarterectomy

  13. Atrial or ventricular septal closure or left atrial appendage closure

  14. Implanted permanent pacemaker, biventricular pacemaker, or any type ofimplantable cardiac defibrillator; loop recorders are permitted.

  15. Presence of intramural thrombus, tumor (including atrial myxoma), or otherabnormality that precludes vascular access, catheter introduction, ormanipulation

  16. Unstable angina

  17. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve

  18. Moderate to severe mitral valve stenosis or other severe valvular disease

  19. Any blood clotting or bleeding abnormalities

  20. Contraindication to systemic anticoagulation

  21. AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible ornon-cardiac cause

  22. Body mass index (BMI) > 40 kg/m2

  23. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratorycondition

  24. Renal failure requiring dialysis or transplant

  25. Acute illness, active systemic infection, or sepsis

  26. Active drug or alcohol dependency

  27. Hypertrophic cardiomyopathy or cardiac amyloidosis

  28. Cor pulmonale

  29. Any contra-indication that may extend procedure time, at the discretion of theoperator

  30. Any woman known to be pregnant or breastfeeding, or any woman of childbearingpotential who is not on a reliable form of birth regulation method or abstinence

  31. Subject considered part of vulnerable population

  32. Life expectancy less than one year

  33. Employee of the study site or Sponsor

  34. Subjects who are currently enrolled in another study that would directly interferewith this study

Study Design

Total Participants: 245
Treatment Group(s): 2
Primary Treatment: CoreMap EP Mapping System Map-Guided Ablation
Phase:
Study Start date:
July 25, 2024
Estimated Completion Date:
December 31, 2026

Study Description

The INvENI Study consists of three phases:

Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent AF (PerAF) and long-standing persistent AF and to demonstrate safety.

Phase 2, the goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and effectiveness of the CoreMap EP Mapping System in patients with PerAF and long-standing persistent AF.

Phase 3, the goal is to evaluate the safety and effectiveness of the CoreMap EP Mapping System's ability to identify spatially constrained AF drivers and guide ablation therapy in PerAF patients with no history of prior AF ablation. This phase aims to demonstrate safety and effectiveness compared to a control arm.

Connect with a study center

  • Na Homolce Hospital

    Praha - Klanovice,
    Czechia

    Site Not Available

  • Na Homolce Hospital

    Praha Klanovice,
    Czechia

    Active - Recruiting

  • NCH Downtown Baker Hospital

    Naples, Florida 34102
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

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