Persistent Atrial FibrillationINvENINCT06529978
Endocardial Mapping With the CoreMap EP Mapping System
A study testing CoreMap EP Mapping System Mapping and CoreMap EP Mapping System Map-Guided Ablation in people with Persistent Atrial Fibrillation, run by CoreMap Inc. at 4 sites in 2 countries.
Trial summary
This is a global, multi-site, prospective, feasibility study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- CoreMap EP Mapping System Mapping and CoreMap EP Mapping System Map-Guided Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Unstable angina
- Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
- Moderate to severe mitral valve stenosis or other severe valvular disease
- Any blood clotting or bleeding abnormalities
- Contraindication to systemic anticoagulation
- AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
- Body mass index (BMI) > 40 kg/m2
- Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
- Renal failure requiring dialysis or transplant
- Acute illness, active systemic infection, or sepsis
- Active drug or alcohol dependency
- Hypertrophic cardiomyopathy or cardiac amyloidosis
- Cor pulmonale
- Any contra-indication that may extend procedure time, at the discretion of the operator
- 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
- Subject considered part of vulnerable population
- Life expectancy less than one year
- Employee of the study site or Sponsor
- Subjects who are currently enrolled in another study that would directly interfere with this study
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Sarah Kalil contact
4 sites in 2 countries
United States3 sites, 3 recruiting
- Enrolling by invitation
University of Vermont Medical Center
Burlington, Vermont, 05401
- Enrolling by invitation
NCH Downtown Baker Hospital
Naples, Florida, 34102
- Enrolling by invitation
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23284
About this study
Official title: Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
This is a global, multi-site, prospective, feasibility study.
Read the detailed 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- CoreMap EP Mapping System Mapping, CoreMap EP Mapping System Map-Guided Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreMap EP Mapping System MappingDevice
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 AblationDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.. Receives: 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. Receives: Device: CoreMap EP Mapping System Mapping; Device: CoreMap EP Mapping System Map-Guided Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phases 1 and Phase 2 Primary Endpoint:
Incidence of study device related serious adverse events within seven (7) days of the study procedure.
Measured: 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.
Measured: 6 and 12 months
Secondary outcomes (3)
Phase 1 Secondary Endpoint:
Successful completion of the intended study mapping procedure with the CoreMap EP Mapping System.
Measured: perioperatively/periprocedurally
Phase 2 Secondary Endpoints:
AF rhythm change or termination following CoreMap-guided ablation.
Measured: perioperatively/periprocedurally
Phase 3 Secondary Endpoints:
AF rhythm change or termination following CoreMap-guided ablation vs. PVI+PW ablation of control arm.
Measured: perioperatively/periprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start25 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoreMap Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Kalil, Study director, CoreMap Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529978
- Sponsor's protocol ID
- CD001
- Acronym
- INvENI
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
- ClinicalTrials.gov ID
- NCT06529978
- Acronym / sponsor ID
- INvENI / CD001
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- CoreMap Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a global, multi-site, prospective, feasibility study.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1- Mapping Only | Experimental | Device: CoreMap EP Mapping System MappingFor 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- Map Guided Ablation | Experimental | Device: CoreMap EP Mapping System Mapping, Device: CoreMap EP Mapping System Map-Guided AblationThe 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.. |
| Phase 3 - Map Guided Ablation | Experimental | Device: CoreMap EP Mapping System Mapping, Device: CoreMap EP Mapping System Map-Guided AblationFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (34 listed)
- Any of the following within three months of enrollment:
- Any of the following within six months of enrollment:
- Any of the following cardiac conditions:
- Contraindication to systemic anticoagulation
- AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoreMap EP Mapping System MappingEndocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF. | Device | Phase 1- Mapping Only, Phase 2- Map Guided Ablation, Phase 3 - Map Guided Ablation |
| CoreMap EP Mapping System Map-Guided AblationInitial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System. | Device | Phase 2- Map Guided Ablation, Phase 3 - Map Guided Ablation |
Primary outcome
Phases 1 and Phase 2 Primary Endpoint:
Time frame: 7 days
Incidence of study device related serious adverse events within seven (7) days of the study procedure.
Phase 2 and Phase 3 Primary Effectiveness Endpoint:
Time frame: 6 and 12 months
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.
3 secondary outcomes
Phase 1 Secondary Endpoint:
Time frame: perioperatively/periprocedurally
Phase 2 Secondary Endpoints:
Time frame: perioperatively/periprocedurally
Phase 3 Secondary Endpoints:
Time frame: perioperatively/periprocedurally
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Kalil contact
Sarah Kalil study director
CoreMap Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoreMap EP Mapping System Mapping and CoreMap EP Mapping System Map-Guided Ablation in people with Persistent Atrial Fibrillation, run by CoreMap Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jim Foster, SysEng (6178723908, jfoster@coremapmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phases 1 and Phase 2 Primary Endpoint: (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.