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 period. The protocol focuses on objectively measurable events rather than presuming that any supplier, manufacturer, distributor, or other organization is responsible for a particular outcome. Study observations may include: Date and time of an initial procurement request. Device manufacturer, model, catalog number, size, configuration, and regulatory status when available. Quantity requested. Supplier or distributor contacted. Quotation availability and quotation response time. Representations regarding inventory or product availability. Account-eligibility or purchasing restrictions communicated to the purchaser. Order acceptance or rejection. Order confirmation and subsequent cancellation. Allocation or back-order status. Estimated and actual fulfillment dates. Shipping and logistics delays. Changes in purchase price or acquisition terms. Requests for purchaser qualification or supporting documentation. Product substitutions or alternative device sourcing. Number of sourcing attempts required to obtain the requested device. Administrative time required to resolve an access issue. Final procurement disposition. The study may compare procurement events according to device type, supplier category, manufacturer, reprocessed versus original-manufacturer product status, acquisition channel, geographic region, purchasing pathway, or other predefined supply-chain characteristics. For participants whose clinical pathway is associated with a documented device-access event, protocol-authorized data may be used to evaluate health-system or procedural consequences. These observations may include the interval between planned and actual procedures, procedure rescheduling, postponement, cancellation, use of an alternative device, changes in procedure planning, additional sourcing requirements, and other predefined measures of clinical-access disruption. The protocol does not require the treating clinician to select a particular ICE catheter. Clinical decisions remain under the control of the treating healthcare professionals and are not dictated by the study. The study does not experimentally withhold a device, create an artificial shortage, intentionally delay a procedure, or direct suppliers to deny or restrict access. A central objective is to distinguish among different categories of supply-chain events, including routine inventory limitations, logistical delays, commercial purchasing restrictions, account-qualification requirements, manufacturer or distributor allocation policies, order-processing failures, cancellations, product discontinuation, and other documented reasons for non-fulfillment. Source documentation may include purchase requests, purchase orders, quotations, invoices, supplier correspondence, distributor communications, order confirmations, cancellation notices, shipping records, catalog information, product identifiers, device availability records, and other contemporaneous procurement documentation. When permitted under the protocol, relevant clinical scheduling or procedural records may also be reviewed to establish the timing and consequence of a documented access event. Each event may be assigned a standardized study identifier and chronology so that the sequence from initial device request through final disposition can be reconstructed. Electronic integrity controls, including document hashing, serialized event identifiers, audit trails, and controlled versioning, may be used to preserve the provenance of research records. These controls are intended to support research data integrity and do not independently establish legal liability or regulatory noncompliance. Potential study endpoints include successful procurement rate, time to confirmed fulfillment, time to delivery, cancellation rate, restriction rate, substitution rate, number of sourcing attempts, acquisition-price variability, administrative burden, and the frequency and duration of associated procedure delays. Exploratory analyses may assess whether particular procurement characteristics are associated with increased time to fulfillment or a higher probability of an access disruption. Analyses may also evaluate patterns of repeated non-fulfillment, variation among supply channels, and differences between represented product availability and documented procurement outcomes. The study is observational and is intended to characterize medical-device access and supply-chain reliability using systematically collected data. Findings may inform healthcare procurement practices, supply-chain resilience strategies, quality-improvement activities, future clinical-access research, and evaluation of medical-device availability without predetermining the conduct or liability of any particular organization.
Study Type
OBSERVATIONAL
Enrollment
200
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.
Truway Health, Inc.
New York, New York, United States
Time to Successful ICE Catheter Procurement
Number of calendar days from the initial documented request for an intracardiac echocardiography catheter to confirmed procurement or fulfillment of the requested device. The measure will be compared between participants associated with a documented device-access disruption and participants with timely device access.
Time frame: From initial procurement request through device fulfillment, up to 90 days
Incidence of ICE Catheter Supply-Chain Disruption
Proportion of observed procurement episodes experiencing at least one predefined supply-chain disruption, including order rejection, cancellation, backorder, allocation, distributor restriction, shipment delay, non-fulfillment, or required substitution of the requested ICE catheter.
Time frame: From initial procurement request through final procurement disposition, up to 90 days
Procedure Delay Associated With ICE Catheter Access
Number and proportion of participants whose planned cardiovascular or electrophysiology procedure is delayed, rescheduled, or otherwise deferred following a documented disruption in access to the required intracardiac echocardiography catheter.
Time frame: From planned procedure scheduling through completion of the procedure, up to 90 days
Time From Planned to Actual Procedure
Number of calendar days between the originally scheduled procedure date and the date the procedure is ultimately performed.
Time frame: Up to 90 days
Rate of Procedure Rescheduling or Cancellation
Proportion of participants whose planned cardiovascular or electrophysiology procedure is rescheduled or cancelled during the observation period, with events classified according to whether a documented ICE catheter access disruption was present.
Time frame: Up to 90 days from the originally scheduled procedure date
ICE Catheter Device Substitution Rate
Proportion of procurement episodes in which the originally requested ICE catheter is replaced with an alternative manufacturer, model, size, reprocessed device, or other clinically acceptable substitute because the requested device could not be obtained as planned.
Time frame: From initial procurement request through procedure completion, up to 90 days
Number of Procurement Attempts Required for Successful Device Access
Total number of documented supplier, distributor, manufacturer, or alternative-source procurement attempts required before the necessary ICE catheter is successfully obtained or the procurement episode is closed without fulfillment.
Time frame: From initial procurement request through final disposition, up to 90 days
ICE Catheter Order Non-Fulfillment Rate
Proportion of submitted procurement requests that are not fulfilled as originally requested because of cancellation, rejection, lack of inventory, purchasing restriction, allocation, distribution limitation, or another documented reason.
Time frame: Up to 90 days following each procurement request
Procurement Administrative Burden
Total documented number of procurement-related contacts, communications, sourcing attempts, account-verification actions, or administrative escalation events required to obtain an ICE catheter or reach final procurement disposition.
Time frame: From initial procurement request through final disposition, up to 90 days
Mean Difference Between Initially Quoted and Final ICE Catheter Acquisition Cost
For each completed procurement episode, the final documented acquisition cost minus the initially quoted or expected acquisition cost will be calculated in U.S. dollars. The outcome will be reported as the mean difference across evaluable procurement episodes. Positive values indicate a higher final cost, and negative values indicate a lower final cost. Episodes without both an initial and final cost will not be included in this outcome.
Time frame: From initial quotation through final acquisition, up to 90 days
Time to Alternative Device Sourcing
Number of calendar days from determination that the originally requested ICE catheter cannot be obtained as planned to confirmation of an alternative clinically acceptable device source.
Time frame: Up to 90 days
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