Endocardial Mapping with the CoreMap EP Mapping System

Last updated: March 14, 2025
Sponsor: CoreMap Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Arrhythmia

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

  2. Subject is 18 to 80 years of age

  3. Patient scheduled for standard of care AF ablation

  4. Subject is able to provide written informed consent

  5. 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: a) Cardiac surgery includingcoronary artery bypass grafting, ventriculotomy, atriotomy b) Thromboembolic event (stroke)

  6. Any of the following cardiac conditions:

  7. New York Heart Association (NYHA) IV

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

  9. Carotid stenting or endarterectomy

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

  11. Implanted permanent pacemaker, biventricular pacemaker, or any type ofimplantable cardiac defibrillator

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

  13. Unstable angina

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

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

  16. Any blood clotting or bleeding abnormalities

  17. Contraindication to systemic anticoagulation

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

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

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

  21. Renal failure requiring dialysis or transplant

  22. Acute illness, active systemic infection, or sepsis

  23. Active drug or alcohol dependency

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

  25. 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

  26. Subject considered part of vulnerable population

  27. Life expectancy less than one year

  28. Employee of the study site or Sponsor

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

Study Design

Total Participants: 150
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. For Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent and long-standing persistent AF. For Phase 2, the goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System. For Phase 3, the goal is the evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate both chronic safety and effectiveness in de novo PerAF patients.

Connect with a study center

  • Na Homolce Hospital

    Praha - Klanovice,
    Czechia

    Active - Recruiting

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