NCT06529978

Endocardial Mapping With the CoreMap EP Mapping System

Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (estimated)
• Sponsor: CoreMap Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	CoreMap EP Mapping System Mapping	Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
DEVICE	CoreMap 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.

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-07-31
• Last updated: 2026-03-11

Locations

3 sites across 2 countries: United States, Czechia

Regulatory

• FDA-regulated device study