Starting soon
Observational
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Condition(s) studied
Cardiovascular DiseasesArrhythmias, CardiacAtrial Fibrillation
Investigational drug(s) / intervention(s)
Intracardiac Echocardiography Catheter
Intracardiac Echocardiography Catheter: 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.
Study summary
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
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 falls within either the documented ICE catheter access-disruption cohort or the timely-access comparison cohort.
* Able to provide informed consent when prospective consent is required by the applicable IRB determination, or eligible for inclusion under an IRB-approved waiver or alteration of consent where applicable.
Exclusion Criteria:
* 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.
* Procedure delay or cancellation is clearly attributable solely to an unrelated clinical or administrative circumstance and no qualifying ICE catheter access event occurred.
* Participation would conflict with another protocol, institutional restriction, or applicable human-subject protection requirement.
* Individuals for whom required authorization, consent, or permitted IRB-approved waiver criteria are not satisfied.
Primary outcome measure(s)
- Time to Successful ICE Catheter Procurement — From initial procurement request through device fulfillment, up to 90 days
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.
- Incidence of ICE Catheter Supply-Chain Disruption — From initial procurement request through final procurement disposition, up to 90 days
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.
- Procedure Delay Associated With ICE Catheter Access — From planned procedure scheduling through completion of the procedure, up to 90 days
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Truway Health, Inc. |
New York |
New York |
|
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