Truway Health, Inc.
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac echocardiography (ICE) catheters and related clinical care. The study will document real-world procurement attempts, fulfillment outcomes, order delays, cancellations, product substitutions, distributor restrictions, acquisition timelines, and other supply-access events involving ICE catheter devices. Where participant-level clinical data are available under the approved protocol, the study will also examine whether device-access problems are associated with procedure delays, rescheduling, changes in planned device use, alternative sourcing, increased administrative burden, or other measurable effects on care delivery. The study does not assign participants to a device or treatment and does not alter clinical decision-making. Procurement and clinical events are observed as they occur in routine practice. The study is intended to develop a structured evidence base for understanding the reliability of the medical-device supply chain and the potential relationship between procurement disruption and timely access to cardiovascular procedures.
Intracardiac echocardiography catheters are specialized medical devices used to provide real-time intracardiac imaging during selected electrophysiology, structural heart, and other cardiovascular procedures. Timely access to these devices may depend on a network of manufacturers, reprocessors, distributors, purchasing organizations, healthcare facilities, logistics providers, and other supply-chain participants. ICE-ACCESS is designed to systematically characterize real-world access to intracardiac echocardiography catheters by recording procurement and fulfillment events over the study peri…
Inclusion Criteria: * Age 18 years or older. * Participant is scheduled for, referred for, or undergoing an electrophysiology, cardiac ablation, structural heart, or other cardiovascular procedure for which intracardiac echocardiography or an ICE catheter is clinically planned, requested, considered, or utilized. * A documented ICE-catheter procurement or device-access episode can be identified and evaluated under the study protocol. * Sufficient procurement, scheduling, clinical, or administrative information is available to determine device-access timing and study outcomes. * Participant fa…
A U.S. FDA-regulated intracardiac echocardiography catheter used to provide real-time intracardiac ultrasound imaging during electrophysiology, cardiac ablation, structural heart, and related cardiovascular procedures. The study does not assign participants to a particular catheter or alter clinical treatment. Instead, it prospectively observes access to the device, including availability, procurement, fulfillment, substitution, and supply-chain disruption, and evaluates associated effects on procedural access and healthcare delivery.