ICE-ACCESS
Prospective Observational Evaluation of Procurement Reliability, Distribution Restrictions, Supply-Chain Disruptions, and Clinical Access to Intracardiac Echocardiography Catheters
Sponsor study identifier
observational
200
1 country
1
Study Start
October 23, 2026
Actual (reported)Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2026
Actual (reported)August 26, 2026
Actual (reported)October 23, 2026
Actual (reported)August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
From initial procurement request through final procurement disposition, up to 90 days
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.
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.
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.
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.
Truway Health, Inc.
New York, New York, 10016, United States
Dravid SG, Hope B, McKinnie JJ. Intracardiac echocardiography in electrophysiology: a review of current applications in practice. Echocardiography. 2008 Nov;25(10):1172-5. doi: 10.1111/j.1540-8175.2008.00784.x.
Isath A, Padmanabhan D, Haider SW, Siroky G, Perimbeti S, Correa A, Chahal CAA, Shenthar J, Asirvatham S, Mehta D. Does the use of intracardiac echocardiography during atrial fibrillation catheter ablation improve outcomes and cost? A nationwide 14-year analysis from 2001 to 2014. J Interv Card Electrophysiol. 2021 Sep;61(3):461-468. doi: 10.1007/s10840-020-00844-5. Epub 2020 Aug 2.
Gavin C Solomon, MD
Truway Health, Inc.
First Submitted
August 23, 2026
First Posted
August 26, 2026
Study Start
October 23, 2026
Actual (reported)Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation
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.
From planned procedure scheduling through completion of the procedure, up to 90 days
Time From Planned to Actual Procedure
Up to 90 days
Rate of Procedure Rescheduling or Cancellation
Up to 90 days from the originally scheduled procedure date
ICE Catheter Device Substitution Rate
From initial procurement request through procedure completion, up to 90 days
Number of Procurement Attempts Required for Successful Device Access
From initial procurement request through final disposition, up to 90 days
ICE Catheter Order Non-Fulfillment Rate
Up to 90 days following each procurement request
Mean Composite Medical Device Access Disruption Index Score
From initial procurement request through procurement disposition, up to 90 days
Contact the study team to confirm eligibility.
Enriquez A, Saenz LC, Rosso R, Silvestry FE, Callans D, Marchlinski FE, Garcia F. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018 May 22;137(21):2278-2294. doi: 10.1161/CIRCULATIONAHA.117.031343.
Alyesh D, Choe W, Demo H, Razminia M, Sundaram S. The Advanced Application of Intracardiac Echocardiography for Cardiac Electrophysiology Ablation Procedures. Curr Cardiol Rep. 2022 May;24(5):505-511. doi: 10.1007/s11886-022-01672-x. Epub 2022 Mar 9.
Gianni C, Sanchez JE, Della Rocca DG, Al-Ahmad A, Horton RP, Di Biase L, Natale A. Intracardiac Echocardiography to Guide Catheter Ablation of Atrial Fibrillation. Card Electrophysiol Clin. 2021 Jun;13(2):303-311. doi: 10.1016/j.ccep.2021.03.009. Epub 2021 Apr 23.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
Individual participant data will not be publicly shared because the study may incorporate confidential clinical, procurement, contractual, commercial, and supply-chain information. Aggregate or appropriately de-identified findings may be reported in publications, regulatory communications, or research summaries consistent with applicable privacy requirements, IRB authorization, and data-use restrictions.
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Source: ClinicalTrials.gov.
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