Endocardial Mapping With the CoreMap EP Mapping System

Part of paid clinical trials in Naples, Florida.

Sponsor
CoreMap Inc.
Study ID
NCT06529978
Status
Recruiting
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Conditions

  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Jul 25, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
245 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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..
  • 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.

Primary Outcome Measure

Phases 1 and Phase 2 Primary Endpoint: [ Time Frame: 7 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NCH Downtown Baker HospitalNaplesFlorida34102-
University of Vermont Medical CenterBurlingtonVermont05401-

Find similar trials in Naples, FL

By research site
NCH Downtown Baker Hospital· Naples, FLUniversity of Vermont Medical Center· Burlington, VT

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