Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTruway Health, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Younger than 18 years of age.
No planned, requested, or clinically relevant intracardiac echocardiography catheter involvement in the associated cardiovascular procedure.
Procurement or clinical records are insufficient to establish the timing or final disposition of the device-access episode.
Device access occurred outside the predefined study observation period.
Trial population
Adults undergoing or scheduled for electrophysiology, cardiac ablation, structural heart, or related cardiovascular procedures in which an intracardiac echocardiography catheter is clinically relevant. Participants will be classified according to whether the associated ICE catheter procurement episode involves a documented access disruption or timely device availability. The population may include individuals associated with procurement events involving original-manufacturer or legally reprocessed ICE catheter products. Clinical treatment decisions remain independent of study participation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intracardiac Echocardiography Catheter
DeviceA 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ICE Catheter Access Disruption Cohort1 intervention
Group B: Timely ICE Catheter Access Cohort1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 days3
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 daysSecondary outcomes
1
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 days2
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 date3
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 days4
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 daysOther outcomes
1
Mean Composite Medical Device Access Disruption Index Score
The Composite Medical Device Access Disruption Index is a sponsor-defined, non-validated eight-item measure of disruption during each procurement episode. The components are: (1) supplier refusal, (2) order cancellation, (3) backorder, (4) purchasing restriction or allocation, (5) shipment delay, (6) two or more documented sourcing attempts, (7) substitution of the requested device, and (8) associated procedure delay, rescheduling, or cancellation. Each component is scored 0 if absent or 1 if present. Total scores range from 0 to 8. Higher scores indicate greater or worse device-access disruption. The outcome will be reported as the mean total score across evaluable procurement episodes.
Time frame
From initial procurement request through procurement disposition, up to 90 daysSponsors and contacts
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Source ClinicalTrials.gov
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