Prospective Observational Evaluation of Procurement Reliability, Distribution Restrictions, Supply-Chain Disruptions, and Clinical Access to Intracardiac Echocardiography Catheters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to Successful ICE Catheter Procurement
研究概览
简要总结
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.
详细描述
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.
ICE-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.
Study observations may include:
Date and time of an initial procurement request. Device manufacturer, model, catalog number, size, configuration, and regulatory status when available.
Quantity 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intracardiac Echocardiography Catheter (Device)
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.
干预措施: Intracardiac Echocardiography Catheter (Device)
结局指标
主要结局
Time to Successful ICE Catheter Procurement
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Procurement Administrative Burden(From initial procurement request through final disposition, up to 90 days)
- Variation in ICE Catheter Acquisition Cost(From initial quotation through final acquisition, up to 90 days)
- Time to Alternative Device Sourcing(Up to 90 days)
- Mean Difference Between Initially Quoted and Final ICE Catheter Acquisition Cost(From initial quotation through final acquisition, up to 90 days)