Endocardial Mapping with the CoreMap EP Mapping System

Not Applicable

Recruiting

• Conditions: Persistent Atrial Fibrillation
• Interventions: Device: CoreMap EP Mapping System Mapping; Device: CoreMap EP Mapping System Map-Guided Ablation

• Registration Number: NCT06529978
• Lead Sponsor: CoreMap Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-24
• Study Start: 2024-07-25
• Study First Submitted QC: 2024-07-27
• Study First Posted: 2024-07-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subject has persistent or long-standing persistent AF, at the discretion of the investigator
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 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: a) Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy b) 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. Carotid stenting or endarterectomy
   4. Atrial or ventricular septal closure or left atrial appendage closure
   5. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator
   6. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
   7. Unstable angina
   8. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
   9. Moderate to severe mitral valve stenosis or other severe valvular disease
   10. 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. Any contra-indication that may extend procedure time, at the discretion of the operator

12. 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

13. Subject considered part of vulnerable population

14. Life expectancy less than one year

15. Employee of the study site or Sponsor

16. Subjects who are currently enrolled in another study that would directly interfere with this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2- Map Guided Ablation	CoreMap EP Mapping System Mapping	The Phase 2 goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy.
Phase 1- Mapping Only	CoreMap EP Mapping System Mapping	For Phase 1, the goal is to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
Phase 2- Map Guided Ablation	CoreMap EP Mapping System Map-Guided Ablation	The Phase 2 goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy.

Primary Outcome Measures

Name	Time	Method
Phases 1 and Phase 2 Primary Endpoint:	7 days	Incidence of study device related serious adverse events within seven (7) days of the study procedure.
Phase 2 and Phase 3 Primary Effectiveness Endpoint:	6 and 12 months	Chronic Efficacy: Freedom from documented recurrence of AF, lasting longer than 30 seconds (excluding the 90-day blanking period) evaluated at 6 and 12 months.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Na Homolce Hospital; 🇨🇿 Praha - Klanovice, Czechia