Endocardial Mapping With the CoreMap EP Mapping System

NCT06529978 | Recruiting FDA Device

• 1 other identifier: CD001
• Study Type: interventional
• Target: 245
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Phase 1 Secondary Endpoint:

  perioperatively/periprocedurally

• Phase 2 Secondary Endpoints:

  perioperatively/periprocedurally

• Phase 3 Secondary Endpoints:

  perioperatively/periprocedurally

Study Arms (3)

Phase 1- Mapping Only

EXPERIMENTAL

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

Phase 2- Map Guided Ablation

EXPERIMENTAL

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; Device: CoreMap EP Mapping System Map-Guided Ablation

Phase 3 - Map Guided Ablation

EXPERIMENTAL

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; Device: CoreMap EP Mapping System Map-Guided Ablation

Interventions

CoreMap EP Mapping System Mapping DEVICE

Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.

Phase 1- Mapping Only; Phase 2- Map Guided Ablation; Phase 3 - Map Guided Ablation

CoreMap EP Mapping System Map-Guided Ablation DEVICE

Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.

Phase 2- Map Guided Ablation; Phase 3 - Map Guided Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
• Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
• Subject is 18 to 80 years of age
• 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)
• Subject is able to provide written informed consent
• Subject is able and willing to complete all study procedures

You may not qualify if:

• Any of the following within three months of enrollment:
• Myocardial infarction (MI)
• Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
• Confirmed thrombus on imaging
• Any of the following within six months of enrollment:
• Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
• Thromboembolic event (stroke)
• Any of the following cardiac conditions:
• New York Heart Association (NYHA) IV
• Left ventricular ejection fraction (LVEF) \< 30%
• Left atrial diameter \>55mm (anterioposterior) (Phase 3)
• Carotid stenting or endarterectomy
• Atrial or ventricular septal closure or left atrial appendage closure
• Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
• Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation

Sponsors & Collaborators

• CoreMap Inc.: lead

Study Sites (3)

NCH Downtown Baker Hospital

Naples, Florida, 34102, United States

ENROLLING BY INVITATION

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

ENROLLING BY INVITATION

Na Homolce Hospital

Praha Klanovice, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Kalil

  CoreMap Inc.

  STUDY DIRECTOR

Central Study Contacts

Jim Foster, SysEng

CONTACT

6178723908; jfoster@coremapmedical.com

Sarah Kalil

CONTACT

skalil@coremapmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 31, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (2); CZ (1)