Hummingbird ICE study
Hummingbird ICE-studie
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of the VeriSight Pro imaging platform.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a prospective, multi-center, open label, observational registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations.
VeriSight Pro catheter is for use with Philips EPIQ series of ultrasound system. VeriSight Pro is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only during cardiac interventional percutaneous procedures and structural heart procedures. A detailed description of VeriSight can be found in the products' IFU.
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. The objective of the study is to collect a comprehensive dataset of raw, de-identified native un-processed ultrasound images and where available collect associated fluoroscopic, CT and MRI images, demographic information and procedural parameters when VeriSight Pro is used in routine percutaneous cardiac intervention procedures and/or ablation procedures. Collected data will be used for development efforts aimed at optimizing image quality, image processing and interoperability of VeriSight Pro imaging platform.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Study Manager
- Telefonnummer: 1 774 249 6135
- E-mail: phil.parthree@philips.com
Undersøgelse Kontakt Backup
- Navn: Ali Kolste
- E-mail: ali.kolste@philips.com
Studiesteder
-
-
Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
-
Kontakt:
- Veronica Gordon
- Telefonnummer: 313-949-2431
- E-mail: vgorden1@hfhs.org
-
Ledende efterforsker:
- Georgi Fram, MD, FACC FASE
-
-
New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cooper Hospital
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Kontakt:
- Erin Siderio
- Telefonnummer: 856-582-2000
- E-mail: esiderio@hearthousenj.com
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Ledende efterforsker:
- John Costello, D.O.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
All subjects age 18 and older that are scheduled for and will undergo a planned cardiac interventional percutaneous procedure in which the guidance of ICE is indicated, eligible and willing to sign an informed consent without meeting any of the exclusion criteria set and meeting all the inclusion criteria set forth in the protocol will be included in the population for analyses.
Beskrivelse
Inclusion Criteria:
- 18 years of age
- Willing to provide written, dated and signed, informed consent
- Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used
Exclusion Criteria:
- Contraindicated for ICE catheter placement or considerations that make placement of VeriSight not technically feasible
- Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease
- Pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Prospective Observational
Prospective observational subjects undergoing planned cardiac procedures utilizing VeriSight image guidance |
VeriSight PRO ICE image guidance
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major procedural complication rate [Safety and Tolerability]
Tidsramme: During procedure
|
Major procedural complication rate (Cardiac perforation, pericardial tamponade, pericardial effusion requiring intervention, major vascular complication requiring intervention or transfusion, procedural related stroke, death or device embolization) related to the device (Verisight Pro) |
During procedure
|
|
Effectiveness (Technical Success)
Tidsramme: During procedure
|
Technical success of VeriSight Pro is defined as: Successful guidance of the treating device to the intended target region, and generation of intracardiac images adequate to visualize the target anatomy relevant to the planned intervention. Technical success is assessed by the Investigator or qualified designee at procedure end. |
During procedure
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Patologiske processer
- Hjertesygdomme
- Arytmier, hjerte
- Medfødte abnormiteter
- Kardiovaskulære abnormiteter
- Hjertefejl, medfødt
- Hjerteseptumdefekter
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Atrieflimren
- Foramen Ovale, Patent
- Hjerteseptumdefekter, atriel
- Hjerteklapsygdomme
Andre undersøgelses-id-numre
- SEF-2025-301281
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data does not need to be shared to meet study objectives.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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