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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
245
Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.
NCH Downtown Baker Hospital
Naples, Florida, United States
ENROLLING_BY_INVITATIONUniversity of Vermont Medical Center
Burlington, Vermont, United States
ENROLLING_BY_INVITATIONVirginia Commonwealth University (VCU)
Richmond, Virginia, United States
ENROLLING_BY_INVITATIONPhases 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
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
Phase 1 Secondary Endpoint:
Successful completion of the intended study mapping procedure with the CoreMap EP Mapping System.
Time frame: perioperatively/periprocedurally
Phase 2 Secondary Endpoints:
AF rhythm change or termination following CoreMap-guided ablation.
Time frame: perioperatively/periprocedurally
Phase 3 Secondary Endpoints:
AF rhythm change or termination following CoreMap-guided ablation vs. PVI+PW ablation of control arm.
Time frame: perioperatively/periprocedurally
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Na Homolce Hospital
Praha Klanovice, Czechia
RECRUITING