Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study

NCT07788040 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: TH-ICEACCESS-2026-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation

Keywords

Intracardiac echocardiography; ICE catheter; AcuNav; Intracardiac ultrasound; Electrophysiology; Cardiac ablation; Structural heart procedures; Medical device availability; Medical device procurement; Supply chain disruption; Healthcare supply chain; Distributor restrictions; Order fulfillment; Procurement delay; Procedure delay; Procedure rescheduling; Device substitution; Alternative sourcing; Clinical access; Healthcare delivery; Supply chain resilience; Medical device distribution; Cardiovascular device access

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• Mean Composite Medical Device Access Disruption Index Score

  From initial procurement request through procurement disposition, up to 90 days

Study Arms (2)

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.

Device: Intracardiac Echocardiography Catheter

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.

Device: Intracardiac Echocardiography Catheter

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.

Also known as: ICE Catheter; Intracardiac Ultrasound Catheter; AcuNav

ICE Catheter Access Disruption Cohort; Timely ICE Catheter Access Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Truway Health, Inc.: lead

Study Sites (1)

Truway Health, Inc.

New York, New York, 10016, United States

Location

Related Publications (5)

• 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.

  PMID: 18986404 BACKGROUND

• 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.

  PMID: 32743700 BACKGROUND

• 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.

  PMID: 29784681 BACKGROUND

• 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.

  PMID: 35260997 BACKGROUND

• 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.

  PMID: 33990269 BACKGROUND

Related Links

• FDA 510(k) - Medline ReNewal Reprocessed ACUSON AcuNav 10F Ultrasound Catheter
• Siemens Healthineers - ACUNAV Intracardiac Echocardiography Catheters

MeSH Terms

Conditions

Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gavin C Solomon, MD

  Truway Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ICE-ACCESS Study Coordination Office

CONTACT

1-833-TRUWAY-1; clinicaltrials@truwayhealth.com

Truway Health Clinical Research Office

CONTACT

833-878-9291; clinicaltrials@truwayhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)