[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653461":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":61,"studyPopulation":62,"armGroups":63,"interventions":73,"overallOfficials":81,"centralContacts":85,"locations":94,"responsibleParty":106,"collaborators":58,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":58,"enrollmentInfo":118,"targetDuration":58,"studyType":121,"phases":58,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":151,"whyStopped":58,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Truway Health, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":52},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":16},"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",{"measure":18,"description":19,"timeFrame":20},"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",[22,26,30,34,38,42,45,49],{"measure":23,"description":24,"timeFrame":25},"Time From Planned to Actual Procedure","Number of calendar days between the originally scheduled procedure date and the date the procedure is ultimately performed.","Up to 90 days",{"measure":27,"description":28,"timeFrame":29},"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.","Up to 90 days from the originally scheduled procedure date",{"measure":31,"description":32,"timeFrame":33},"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.","From initial procurement request through procedure completion, up to 90 days",{"measure":35,"description":36,"timeFrame":37},"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.","From initial procurement request through final disposition, up to 90 days",{"measure":39,"description":40,"timeFrame":41},"ICE Catheter Order Non-Fulfillment Rate","Proportion of submitted procurement requests that are not fulfilled as originally requested because of cancellation, rejection, lack of inventory, purchasing restriction, allocation, distribution limitation, or another documented reason.","Up to 90 days following each procurement request",{"measure":43,"description":44,"timeFrame":37},"Procurement Administrative Burden","Total documented number of procurement-related contacts, communications, sourcing attempts, account-verification actions, or administrative escalation events required to obtain an ICE catheter or reach final procurement disposition.",{"measure":46,"description":47,"timeFrame":48},"Mean Difference Between Initially Quoted and Final ICE Catheter Acquisition Cost","For each completed procurement episode, the final documented acquisition cost minus the initially quoted or expected acquisition cost will be calculated in U.S. dollars. The outcome will be reported as the mean difference across evaluable procurement episodes. Positive values indicate a higher final cost, and negative values indicate a lower final cost. Episodes without both an initial and final cost will not be included in this outcome.","From initial quotation through final acquisition, up to 90 days",{"measure":50,"description":51,"timeFrame":25},"Time to Alternative Device Sourcing","Number of calendar days from determination that the originally requested ICE catheter cannot be obtained as planned to confirmation of an alternative clinically acceptable device source.",[53],{"measure":54,"description":55,"timeFrame":56},"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.","From initial procurement request through procurement disposition, up to 90 days",{"allocation":58,"interventionModel":58,"interventionModelDescription":58,"primaryPurpose":58,"observationalModel":59,"timePerspective":60,"maskingInfo":58},null,"COHORT","PROSPECTIVE","Intracardiac echocardiography catheters are specialized medical devices used to provide real-time intracardiac imaging during selected electrophysiology, structural heart, and other cardiovascular procedures. Timely access to these devices may depend on a network of manufacturers, reprocessors, distributors, purchasing organizations, healthcare facilities, logistics providers, and other supply-chain participants.\n\nICE-ACCESS is designed to systematically characterize real-world access to intracardiac echocardiography catheters by recording procurement and fulfillment events over the study period. The protocol focuses on objectively measurable events rather than presuming that any supplier, manufacturer, distributor, or other organization is responsible for a particular outcome.\n\nStudy observations may include:\n\nDate and time of an initial procurement request. Device manufacturer, model, catalog number, size, configuration, and regulatory status when available.\n\nQuantity requested. Supplier or distributor contacted. Quotation availability and quotation response time. Representations regarding inventory or product availability. Account-eligibility or purchasing restrictions communicated to the purchaser. Order acceptance or rejection. Order confirmation and subsequent cancellation. Allocation or back-order status. Estimated and actual fulfillment dates. Shipping and logistics delays. Changes in purchase price or acquisition terms. Requests for purchaser qualification or supporting documentation. Product substitutions or alternative device sourcing. Number of sourcing attempts required to obtain the requested device. Administrative time required to resolve an access issue. Final procurement disposition.\n\nThe study may compare procurement events according to device type, supplier category, manufacturer, reprocessed versus original-manufacturer product status, acquisition channel, geographic region, purchasing pathway, or other predefined supply-chain characteristics.\n\nFor participants whose clinical pathway is associated with a documented device-access event, protocol-authorized data may be used to evaluate health-system or procedural consequences. These observations may include the interval between planned and actual procedures, procedure rescheduling, postponement, cancellation, use of an alternative device, changes in procedure planning, additional sourcing requirements, and other predefined measures of clinical-access disruption.\n\nThe protocol does not require the treating clinician to select a particular ICE catheter. Clinical decisions remain under the control of the treating healthcare professionals and are not dictated by the study. The study does not experimentally withhold a device, create an artificial shortage, intentionally delay a procedure, or direct suppliers to deny or restrict access.\n\nA central objective is to distinguish among different categories of supply-chain events, including routine inventory limitations, logistical delays, commercial purchasing restrictions, account-qualification requirements, manufacturer or distributor allocation policies, order-processing failures, cancellations, product discontinuation, and other documented reasons for non-fulfillment.\n\nSource documentation may include purchase requests, purchase orders, quotations, invoices, supplier correspondence, distributor communications, order confirmations, cancellation notices, shipping records, catalog information, product identifiers, device availability records, and other contemporaneous procurement documentation. When permitted under the protocol, relevant clinical scheduling or procedural records may also be reviewed to establish the timing and consequence of a documented access event.\n\nEach event may be assigned a standardized study identifier and chronology so that the sequence from initial device request through final disposition can be reconstructed. Electronic integrity controls, including document hashing, serialized event identifiers, audit trails, and controlled versioning, may be used to preserve the provenance of research records. These controls are intended to support research data integrity and do not independently establish legal liability or regulatory noncompliance.\n\nPotential study endpoints include successful procurement rate, time to confirmed fulfillment, time to delivery, cancellation rate, restriction rate, substitution rate, number of sourcing attempts, acquisition-price variability, administrative burden, and the frequency and duration of associated procedure delays.\n\nExploratory analyses may assess whether particular procurement characteristics are associated with increased time to fulfillment or a higher probability of an access disruption. Analyses may also evaluate patterns of repeated non-fulfillment, variation among supply channels, and differences between represented product availability and documented procurement outcomes.\n\nThe study is observational and is intended to characterize medical-device access and supply-chain reliability using systematically collected data. Findings may inform healthcare procurement practices, supply-chain resilience strategies, quality-improvement activities, future clinical-access research, and evaluation of medical-device availability without predetermining the conduct or liability of any particular organization.","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.",[64,69],{"label":65,"type":58,"description":66,"interventionNames":67},"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.",[68],"Device: Intracardiac Echocardiography Catheter",{"label":70,"type":58,"description":71,"interventionNames":72},"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.",[68],[74],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"DEVICE","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.",[65,70],[80],"ICE Catheter; Intracardiac Ultrasound Catheter; AcuNav",[82],{"name":83,"affiliation":5,"role":84},"Gavin C Solomon, MD","PRINCIPAL_INVESTIGATOR",[86,91],{"name":87,"role":88,"phone":89,"phoneExt":58,"email":90},"ICE-ACCESS Study Coordination Office","CONTACT","1-833-TRUWAY-1","clinicaltrials@truwayhealth.com",{"name":92,"role":88,"phone":93,"phoneExt":58,"email":90},"Truway Health Clinical Research Office","833-878-9291",[95],{"facility":5,"status":58,"city":96,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":58},"New York","10016","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-74.00597,40.71427,{"lat":104,"lon":103},{"type":107,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100653461","intracardiac-echocardiography-catheter-supply-chain-reliability-and-clinical-access-study-100653461",false,"NCT07788040","Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study","Prospective Observational Evaluation of Procurement Reliability, Distribution Restrictions, Supply-Chain Disruptions, and Clinical Access to Intracardiac Echocardiography Catheters","ICE-ACCESS","Inclusion Criteria:\n\n* Age 18 years or older.\n* 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.\n* A documented ICE-catheter procurement or device-access episode can be identified and evaluated under the study protocol.\n* Sufficient procurement, scheduling, clinical, or administrative information is available to determine device-access timing and study outcomes.\n* Participant falls within either the documented ICE catheter access-disruption cohort or the timely-access comparison cohort.\n* 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.\n\nExclusion Criteria:\n\n* Younger than 18 years of age.\n* No planned, requested, or clinically relevant intracardiac echocardiography catheter involvement in the associated cardiovascular procedure.\n* Procurement or clinical records are insufficient to establish the timing or final disposition of the device-access episode.\n* Device access occurred outside the predefined study observation period.\n* Procedure delay or cancellation is clearly attributable solely to an unrelated clinical or administrative circumstance and no qualifying ICE catheter access event occurred.\n* Participation would conflict with another protocol, institutional restriction, or applicable human-subject protection requirement.\n* Individuals for whom required authorization, consent, or permitted IRB-approved waiver criteria are not satisfied.","ALL","18 Years",{"count":119,"type":120},200,"ESTIMATED","OBSERVATIONAL","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.\n\nWhere 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.\n\nThe 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.",[124,125,126],"Cardiovascular Diseases","Arrhythmias, Cardiac","Atrial Fibrillation",[128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"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","NOT_YET_RECRUITING","2026-08-25",{"date":154,"type":155},"2026-08-28","ACTUAL",{"date":157,"type":120},"2026-09-01",{"date":159,"type":120},"2027-09-30",{"name":5,"class":6},1]