CoreMap EP Mapping System for Atrial Fibrillation

(INvENI Trial)

Recruiting at 3 trial locations

Overseen By Sarah Kalil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CoreMap Inc.

Disqualifiers: Myocardial infarction, Stroke, Severe valvular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

245 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a new technology called the CoreMap EP Mapping System to help treat atrial fibrillation (AF), a heart condition that causes irregular and rapid heartbeats. The study will explore how effectively this system maps the heart's electrical signals and guides ablation therapy, a treatment that destroys small areas of heart tissue causing abnormal rhythms. The trial seeks participants with persistent or long-standing atrial fibrillation, particularly those who have not undergone prior AF ablation therapy and experience AF symptoms impacting daily life. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future AF treatments.

What prior data suggests that the CoreMap EP Mapping System is safe for atrial fibrillation patients?

Research has shown that the CoreMap EP Mapping System is safe and effective in over 50 patients. This system maps the heart's electrical activity in individuals with atrial fibrillation (AF), a common heart rhythm issue. These studies have reported no serious safety problems. The system aids doctors in identifying problematic areas in the heart that may cause AF, reducing the risk of harming healthy tissue during treatment. Overall, this suggests that the CoreMap EP Mapping System is well-tolerated in patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CoreMap EP Mapping System for atrial fibrillation (AF) because it offers a cutting-edge method to pinpoint and treat the drivers of AF more precisely. Unlike standard treatments, such as medication or traditional ablation techniques, this system uses high-fidelity electrograms to create detailed maps of the heart's electrical activity. This precision can guide more effective ablation strategies, potentially leading to better outcomes for patients with persistent and long-standing AF. By focusing on identifying spatially constrained AF drivers, the CoreMap system aims to enhance safety and effectiveness compared to current options.

What evidence suggests that the CoreMap EP Mapping System is effective for atrial fibrillation?

Research has shown that the CoreMap EP Mapping System holds promise for treating atrial fibrillation (AF). In a study with over 50 patients, it proved safe and effective in the short term. This trial includes different phases to evaluate the system's capabilities. In Phase 1, participants undergo mapping only to collect and analyze high-fidelity endocardial electrograms. Phase 2 involves map-guided ablation to develop and evaluate a tailored ablation strategy. Phase 3 further assesses the system's ability to identify AF drivers and guide ablation therapy, comparing its safety and effectiveness to a control arm. This system helps doctors find the exact spots in the heart that cause AF, allowing for more precise treatment. Studies indicate that this can lead to more successful procedures to correct heart rhythm issues. By helping doctors pinpoint the areas that sustain the abnormal rhythm, the CoreMap system could improve results for patients with ongoing AF. ^{1 2 5 6 7}

Who Is on the Research Team?

Sarah Kalil

Principal Investigator

CoreMap Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is able to provide written informed consent

I am able and willing to follow all study procedures.

I have symptoms from atrial fibrillation and am scheduled for an ablation procedure.

Exclusion Criteria

I have a serious lung or chronic breathing condition.

I have had a heart attack, heart procedure, or blood clot in the past three months.

BMI > 40 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Mapping Only

Collection and analysis of high fidelity endocardial electrograms (EGMs) in patients with persistent AF and long-standing persistent AF to demonstrate safety.

Perioperative

1 visit (in-person)

Phase 2 - Map Guided Ablation

Initial development and evaluation of a CoreMap-guided tailored ablation strategy to demonstrate safety and effectiveness.

Perioperative

1 visit (in-person)

Phase 3 - Map Guided Ablation

Evaluation 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.

Perioperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CoreMap EP Mapping System

How Is the Trial Designed?

Group I: Phase 3 - Map Guided Ablation Experimental Treatment 2 Interventions

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.

Group II: Phase 2- Map Guided Ablation Experimental Treatment 2 Interventions

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..

Group III: Phase 1- Mapping Only Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

CoreMap Inc.

Lead Sponsor

Trials

1

Recruited

150+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06529978

Endocardial Mapping With the CoreMap EP Mapping System

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 ...

2.

ctv.veeva.com

ctv.veeva.com/study/endocardial-mapping-with-the-coremap-ep-mapping-system

Endocardial Mapping With the CoreMap EP Mapping System

The INvENI Study consists of three phases: Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12661062/

The Clinical Utility of 3D Electroanatomical Mapping for Atrial ...

Real World Application of Pulsed Field Ablation. Our data show that PFA is an effective treatment for AF ablation with 78% of patients' ...

4.

trial.medpath.com

trial.medpath.com/news/13612f3338d11b48/coremap-receives-fda-ide-approval-to-expand-novel-atrial-fibrillation-mapping-technology-study-to-u-s

CoreMap Receives FDA IDE Approval to Expand Novel Atrial ...

To date, CoreMap has demonstrated safety and acute effectiveness of its EP Mapping system in over 50 patients. Revolutionary Mapping Technology Addresses ...

5.

biospace.com

biospace.com/press-releases/coremap-inc-receives-u-s-fda-investigational-device-exemption-ide-approval-for-inveni-map-guided-af-ablation-study

CoreMap, Inc. Receives U.S. FDA Investigational Device ...

To date, CoreMap has demonstrated safety and acute effectiveness of its EP Mapping system in over 50 patients. Dr. Vivek Reddy, the Helmsley ...

6.

cms.gov

cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved/g240246-nct06529978

G240246-NCT06529978

Life Safety Code ... Endocardial Mapping with the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol. Sponsor Name.

7.

nature.com

nature.com/articles/s41591-024-03114-3

Safety of pulsed field ablation in more than 17000 patients ...

These data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation.