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Can broken supply chains delay heart procedures? a new study investigates

NCT ID NCT07788040

Knowledge-focused Sponsor: Truway Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study observes how supply chain problems affect the availability of intracardiac echocardiography (ICE) catheters, which are used during certain heart procedures. Researchers will track real-world procurement attempts, including delays, cancellations, and substitutions, to see if these issues lead to postponed or rescheduled procedures. The study does not assign any treatment; it simply watches what happens in routine care to understand the impact of device shortages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intracardiac echocardiography (ICE) catheter
What this could lead to
If successful, this could identify weak points in the medical device supply chain and inform strategies to prevent procedure delays for heart patients.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may be limited by the specific hospitals and supply chain situations observed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation cardiac rhythm disease cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arrhythmias, cardiac Atrial fibrillation Cardiovascular diseases Cardiovascular medical device procurement Clinical effects of device availability Healthcare delivery and procedure access Intracardiac echocardiography catheter access Medical device supply chain disruption

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Truway Health, Inc.

    New York, New York, 10016, United States

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