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This is a global, multi-site, prospective, feasibility study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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.. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Secondary Endpoint: | Successful completion of the intended study mapping procedure with the CoreMap EP Mapping System. | perioperatively/periprocedurally |
| Phase 2 Secondary Endpoints: | AF rhythm change or termination following CoreMap-guided ablation. |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jim Foster, SysEng | Contact | 6178723908 | jfoster@coremapmedical.com | |
| Sarah Kalil | Contact | skalil@coremapmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Kalil | CoreMap Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCH Downtown Baker Hospital | Enrolling by invitation | Naples | Florida | 34102 | United States | |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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. |
|
| perioperatively/periprocedurally |
| Phase 3 Secondary Endpoints: | AF rhythm change or termination following CoreMap-guided ablation vs. PVI+PW ablation of control arm. | perioperatively/periprocedurally |
| University of Vermont Medical Center |
| Enrolling by invitation |
| Burlington |
| Vermont |
| 05401 |
| United States |
| Na Homolce Hospital | Recruiting | Praha Klanovice | Czechia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |