Philips Intracardiac Echocardiography (ICE) klinisk register
Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States 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. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter.
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- University of Colorado
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60208
- Northwestern University
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
-
-
Texas
-
Austin, Texas, Forenede Stater, 78705
- Texas Cardiac Arrhythmia Research Foundation
-
-
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 and willing to provide written, dated and signed, informed consent
- Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)
Exclusion Criteria:
- Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible
- If alternate access (as needed instead of femoral) is not viable
- 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.
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 image guidance |
ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Technical Success
Tidsramme: During procedure
|
Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure |
During procedure
|
|
Imaging Success
Tidsramme: During procedure
|
Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator |
During procedure
|
|
Clinical Success
Tidsramme: During procedure
|
Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. |
During procedure
|
|
Number of Participants With Device-related Adverse Event Detection
Tidsramme: Procedure through 48 hours or discharge, whichever is earlier
|
Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier. |
Procedure through 48 hours or discharge, whichever is earlier
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Rashmi Ram, PhD, Philips Clinical and Medical Affairs
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Nøgleord
Yderligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- 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
- Aortaklapsygdom
- Slag
- Atrieflimren
- Foramen Ovale, Patent
- Hjerteseptumdefekter, atriel
- Hjerteklapsygdomme
Andre undersøgelses-id-numre
- 2019_10745
- 2019 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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