Endocardial Mapping With the CoreMap EP Mapping System (INvENI)

Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol

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

Study Overview

• Status: Recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: CoreMap EP Mapping System Mapping; Device: CoreMap EP Mapping System Map-Guided Ablation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 245
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jim Foster, SysEng; Phone Number: 6178723908; Email: jfoster@coremapmedical.com
• Study Contact Backup: Name: Sarah Kalil; Email: skalil@coremapmedical.com

Study Locations

• Czechia
  • Praha Klanovice, Czechia
    • Recruiting
    • Na Homolce Hospital
• United States
  • Florida
    • Naples, Florida, United States, 34102
      • Enrolling by invitation
      • NCH Downtown Baker Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Enrolling by invitation
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject has persistent or long-standing persistent AF, at the discretion of the investigator (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 clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-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 Criteria:

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

   1. Myocardial infarction (MI)
   2. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
   3. Confirmed thrombus on imaging

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

   1. Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
   2. Thromboembolic event (stroke)

3. Any of the following cardiac conditions:

   1. New York Heart Association (NYHA) IV
   2. Left ventricular ejection fraction (LVEF) < 30%
   3. Left atrial diameter >55mm (anterioposterior) (Phase 3)
   4. Carotid stenting or endarterectomy
   5. Atrial or ventricular septal closure or left atrial appendage closure
   6. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
   7. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
   8. Unstable angina
   9. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
   10. Moderate to severe mitral valve stenosis or other severe valvular disease
   11. Any blood clotting or bleeding abnormalities
4. Contraindication to systemic anticoagulation
5. AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
6. Body mass index (BMI) > 40 kg/m2
7. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
8. Renal failure requiring dialysis or transplant
9. Acute illness, active systemic infection, or sepsis
10. Active drug or alcohol dependency
11. Hypertrophic cardiomyopathy or cardiac amyloidosis
12. Cor pulmonale
13. Any contra-indication that may extend procedure time, at the discretion of the operator
14. 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
15. Subject considered part of vulnerable population
16. Life expectancy less than one year
17. Employee of the study site or Sponsor
18. Subjects who are currently enrolled in another study that would directly interfere with this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1- Mapping Only; For 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.	Device: CoreMap EP Mapping System Mapping; Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
Experimental: Phase 2- Map Guided Ablation; The Phase 2 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..	Device: CoreMap EP Mapping System Mapping; Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.; Device: CoreMap EP Mapping System Map-Guided Ablation; Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.
Experimental: Phase 3 - Map Guided Ablation; For 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 therapy. This phase aims to demonstrate safety and effectiveness compared to a control arm.	Device: CoreMap EP Mapping System Mapping; Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.; Device: CoreMap EP Mapping System Map-Guided Ablation; Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phases 1 and Phase 2 Primary Endpoint:	Incidence of study device related serious adverse events within seven (7) days of the study procedure.	7 days
Phase 2 and Phase 3 Primary Effectiveness Endpoint:	Freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through a 12-month follow-up and excluding a 90-day blanking period.	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 Secondary Endpoint:	Successful completion of the intended study mapping procedure with the CoreMap EP Mapping System.	perioperatively/periprocedurally
Phase 2 Secondary Endpoints:	AF rhythm change or termination following CoreMap-guided ablation.	perioperatively/periprocedurally
Phase 3 Secondary Endpoints:	AF rhythm change or termination following CoreMap-guided ablation vs. PVI+PW ablation of control arm.	perioperatively/periprocedurally

Collaborators and Investigators

• Sponsor: CoreMap Inc.
• Investigators: Study Director: Sarah Kalil, CoreMap Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: CD001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes