Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
CoreMap Inc.
Summary
This is a global, multi-site, prospective, feasibility study.
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…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2) 2. Subject has PerAF with no history of prior AF ablation therapy (Phase 3) 3. Subject is 18 to 80 years of age 4. 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) 5. Subject is able to provide written informed consent 6. Subject is able and willing to complete all study procedures Exclusion Criteria: 1. Any of the following within th…
Interventions
- DeviceCoreMap EP Mapping System Mapping
Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
- DeviceCoreMap EP Mapping System Map-Guided Ablation
Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.
Locations (3)
- NCH Downtown Baker HospitalNaples, Florida
- University of Vermont Medical CenterBurlington, Vermont
- Na Homolce HospitalPraha Klanovice