Endocardial Mapping With the CoreMap EP Mapping System (INvENI)

CoreMap Inc.

Status: Enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Device: CoreMap EP Mapping System Map-Guided Ablation; Device: CoreMap EP Mapping System Mapping

Study type: Interventional

Funder types: Industry

Identifiers

NCT06529978

CD001

Details and patient eligibility

About

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

Full 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.

Enrollment: 245 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

245 participants in 3 patient groups

Phase 1- Mapping Only

Experimental group

Description:

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.

Treatment:

Device: CoreMap EP Mapping System Mapping

Phase 2- Map Guided Ablation

Experimental group

Description:

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..

Treatment:

Device: CoreMap EP Mapping System Mapping

Device: CoreMap EP Mapping System Map-Guided Ablation

Phase 3 - Map Guided Ablation

Experimental group

Description:

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.

Treatment:

Device: CoreMap EP Mapping System Mapping

Device: CoreMap EP Mapping System Map-Guided Ablation