Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study

Conditions

• Cardiovascular Medical Device Procurement
• Clinical Effects of Device Availability
• Healthcare Delivery and Procedure Access
• Intracardiac Echocardiography Catheter Access
• Medical Device Supply Chain Disruption

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intracardiac Echocardiography Catheter — DEVICE
  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 Details

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.

Key Dates

First listed

Aug 26, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: ICE Catheter Access Disruption Cohort
  Participants whose planned electrophysiology, cardiac ablation, structural heart, or other cardiovascular care involves a documented disruption in access to an intracardiac echocardiography catheter. Qualifying events may include procurement delay, supplier non-fulfillment, order cancellation, backorder, allocation, purchasing restriction, distribution restriction, shipment delay, or required substitution of the originally requested ICE catheter. Participants are observed prospectively for device-access timelines and associated procedural or healthcare-delivery outcomes.
• Arm: Timely ICE Catheter Access Cohort
  Participants undergoing comparable cardiovascular procedures for whom the required intracardiac echocardiography catheter is available and obtained without a qualifying procurement or supply-chain disruption. This cohort serves as the observational comparison group for evaluating time to procedure, rescheduling, device substitution, procurement burden, and other predefined healthcare-delivery outcomes.

Primary Outcome Measure

Time to Successful ICE Catheter Procurement [ Time Frame: From initial procurement request through device fulfillment, up to 90 days ]

Central Contacts

• ICE-ACCESS Study Coordination Office
  1-833-TRUWAY-1
  [email protected]

Locations (1)

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