Trials Sponsors Conditions Drugs Pricing

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 MappingDevice: CoreMap EP Mapping System Map-Guided Ablation

Phase 3 - Map Guided Ablation

EXPERIMENTAL

Interventions

CoreMap EP Mapping System MappingDevice

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

Phase 1- Mapping OnlyPhase 2- Map Guided AblationPhase 3 - Map Guided Ablation

CoreMap EP Mapping System Map-Guided AblationDevice

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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)

Sponsors & Collaborators

CoreMap Inc.
Industrylead

Study Sites (4)

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

Virginia Commonwealth University (VCU)

Richmond, Virginia, 23284, United States

ENROLLING_BY_INVITATION

Na Homolce Hospital

Praha Klanovice, Czechia

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological 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

Actual (reported)

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Endocardial Mapping With the CoreMap EP Mapping System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

Phase 1- Mapping Only

Phase 2- Map Guided Ablation

Phase 3 - Map Guided Ablation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

Phase 1- Mapping Only

Phase 2- Map Guided Ablation

Phase 3 - Map Guided Ablation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations