Health TrialsbyHealthPanel

Endocardial Mapping With the CoreMap EP Mapping System

ConditionPersistent Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCoreMap Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Myocardial infarction (MI)

Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation

Confirmed thrombus on imaging

Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

245 Participants
are divided into 3 treatment groups
Group A: Phase 1- Mapping OnlyExperimental treatment 1 intervention
Group B: Phase 2- Map Guided AblationExperimental treatment 2 interventions
Group C: Phase 3 - Map Guided AblationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phases 1 and Phase 2 Primary Endpoint:

Incidence of study device related serious adverse events within seven (7) days of the study procedure.

Time frame
7 days
2

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.

Time frame
6 and 12 months

Secondary outcomes

1

Phase 1 Secondary Endpoint:

Successful completion of the intended study mapping procedure with the CoreMap EP Mapping System.

Time frame
perioperatively/periprocedurally
2

Phase 2 Secondary Endpoints:

AF rhythm change or termination following CoreMap-guided ablation.

Time frame
perioperatively/periprocedurally
3

Phase 3 Secondary Endpoints:

AF rhythm change or termination following CoreMap-guided ablation vs. PVI+PW ablation of control arm.

Time frame
perioperatively/periprocedurally

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CoreMap Inc.

Lead sponsor

Source ClinicalTrials.gov
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