Clinical Application of a New Handheld ECG Device (CANHED)
To investigate possible heart disease, an electrocardiogram (ECG) is needed. For this, a person usually must go to the hospital, sometimes urgently. There, an ECG is performed using a device with 10 wires attached to the skin with adhesive pads or suction cups. Taken together, a time-consuming procedure.
With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing.
With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing.
By holding this new device against the chest, a heart recording is made and stored via a smartphone so that it can be remotely reviewed by a doctor.
The goal of this study is to establish that the new method of ECG registration is at least as good as the conventional way.
The number of successfully completed (suitable for interpretation) ECGs will be compared to the total number of ECG registrations; also, the number of adverse events will be scored as well as user satisfaction.
There are no risks associated with participating in this study. The burden is minimal: an extra ECG within 1 minute without using any adhesives or wires.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Cardiovascular diseases (CVD) affect around 620Mn people, 1 in 13 of the world's population. The number of people affected is increasing due to changing lifestyles and a growing and aging population. CVDs are a leading cause of mortality and morbidity worldwide. They place a significant burden on healthcare systems, government budgets, and the lives of patients and caregivers. In 2019, CVDs accounted for 17.9Mn deaths worldwide - 32% of all deaths.
Specifically, heart attacks and strokes were responsible for 85% of these deaths, with a third occurring prematurely in individuals under 70 years4. The total annual costs of CVDs, including healthcare costs, productivity losses, and informal care, are estimated to be around €210Bn in Europe and €380Bn in the US.
Over the past decades, significant progress in CVD diagnostics has resulted in a wide range of diagnostic tools. However, the gold-standard 12-lead ECG remains indispensable for accurately detecting complex and life-threatening cardiac conditions like myocardial infarction (MI). While simpler devices provide convenience, they lack the precision needed for diagnosing such critical pathologies.
HeartEye is a Dutch pioneering medical technology company that has developed and aims to receive regulatory approvals of a handheld ECG device to provide accessible, accurate, and user-friendly electrocardiogram (ECG) diagnostics through innovative technology, and portable, medical-grade devices that empower individuals and healthcare professionals (HCPs) with timely and precise cardiac health insights.
To test the employment, feasibility, clinical performance, and safety of HeartEye's ECG device, 594 patients admitted to the hospital will be enrolled for (near) simultaneous registration of a standard ECG and a HeartEye ECG for comparison of diagnosis by an independent expert panel of cardiologists to assess the degree of agreement. A HeartEye ECG can be performed within 60 seconds by simply holding the device against the chest without the use of adhesives, thereby causing minimal burden or risks for patients, if any.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Rien van der Zee, MD, PhD
- Telefonní číslo: +31 6 55756354
- E-mail: rien@hearteye.nl
Studijní záloha kontaktů
- Jméno: Tjebbe Tauber, MSc
- Telefonní číslo: +31 6 27190280
- E-mail: tjebbe@hearteye.nl
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
To be eligible for enrolment in this study after adequately being informed, a participant must meet all the following criteria:
Adult (>18years old) patients admitted to the Meander Medical Centre Amersfoort (NL) or the Catharina Hospital Eindhoven (NL) visiting the outpatient clinic with a known cardiac condition or complaints suspected of cardiac disease.
Exclusion Criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Not intact skin condition in the sternal area (e.g. recent thoracic surgery, skin eruptions, caustic trauma, etc.)
- Unable to understand the procedure (e.g. comatose, incapacitated, or critically ill patients).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Patients visiting a hospital that are scheduled for an ECG registration receive 1 additional ECG
Patients diagnosed with various conditions will be selected to create a diverse mixture of cardiac pathology in the following categories:
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Patients admitted to the hospital that are subjected to routine ECG registration can be enrolled in the study by adding a HeartEye ECG nearly simultaneously, meaning within 5 minutes before or after the routine ECG registration.
Another 60 seconds per ECG added to the procedure due to enrolment in this study, causing a minimal burden for the patient.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Primary Objective: To test non-inferiority, diagnostic agreement of the 12 lead HeartEye ECG will be determined by comparing individual cardiologist diagnosis per category to the traditional ECG.
Časové okno: 4 months after first inclusion.
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4 months after first inclusion.
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Zepeda-Echavarria A, van de Leur RR, Vessies M, de Vries NM, van Sleuwen M, Hassink RJ, Wildbergh TX, van Doorn JL, van der Zee R, Doevendans PA, Jaspers JEN, van Es R. Detection of acute coronary occlusion with a novel mobile electrocardiogram device: a pilot study. Eur Heart J Digit Health. 2024 Jan 17;5(2):183-191. doi: 10.1093/ehjdh/ztae002. eCollection 2024 Mar.
- de Vries NM, Zepeda-Echavarria A, van de Leur RR, Loen V, Vos MA, Boonstra MJ, Wildbergh TX, Jaspers JEN, van der Zee R, Slump CH, Doevendans PA, van Es R. Detection of Ischemic ST-Segment Changes Using a Novel Handheld ECG Device in a Porcine Model. JACC Adv. 2023 Jul 19;2(5):100410. doi: 10.1016/j.jacadv.2023.100410. eCollection 2023 Jul.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- NL011365
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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