Hummingbird ICE-studien
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Clinical Study Manager
- Telefonnummer: 1 774 249 6135
- E-post: phil.parthree@philips.com
Studer Kontakt Backup
- Navn: Ali Kolste
- E-post: ali.kolste@philips.com
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
-
Ta kontakt med:
- Veronica Gordon
- Telefonnummer: 313-949-2431
- E-post: vgorden1@hfhs.org
-
Hovedetterforsker:
- Georgi Fram, MD, FACC FASE
-
-
New Jersey
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Camden, New Jersey, Forente stater, 08103
- Cooper Hospital
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Ta kontakt med:
- Erin Siderio
- Telefonnummer: 856-582-2000
- E-post: esiderio@hearthousenj.com
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Hovedetterforsker:
- John Costello, D.O.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Prospective Observational
Prospective observational subjects undergoing planned cardiac procedures utilizing VeriSight image guidance |
VeriSight PRO ICE image guidance
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Hjertesykdommer
- Arytmier, hjerte
- Medfødte abnormiteter
- Kardiovaskulære abnormiteter
- Hjertefeil, medfødt
- Hjerteseptumdefekter
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Patologiske tilstander, tegn og symptomer
- Atrieflimmer
- Foramen Ovale, patent
- Hjerteseptumdefekter, atrie
- Hjerteklaffsykdommer
Andre studie-ID-numre
- SEF-2025-301281
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data does not need to be shared to meet study objectives.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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