VitaFlow LIBERTY Europa
VitaFlow Liberty™ Transkatheter Aortaklepsysteem Klinisch vervolgonderzoek na het op de markt brengen
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.
Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Zhujun Cai, PhD
- Telefoonnummer: 86-021-38954600
- E-mail: zjcai@microport.com
Studie Contact Back-up
- Naam: Yann Poezevara, PhD
- Telefoonnummer: 0033-146013409
- E-mail: Yann.Poezevara@cf.microport.com
Studie Locaties
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Galway, Ierland
- Werving
- Galway University Hospital
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Contact:
- Darren Mylotte, MD
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Castel Volturno, Italië
- Werving
- Pineta Grande Hospital
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Contact:
- Alberto Morello
- Telefoonnummer: +393397904191
- E-mail: albertomorello83@gmail.com
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Pisa, Italië
- Werving
- Ospedale Cisanello
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Contact:
- Dr.Marco De Carlo
- Telefoonnummer: +39 050 971 9530
- E-mail: urp@ao-pisa.toscana.it
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Potenza, Italië
- Werving
- Azienda Ospedaliera Regionale -S.Carlo
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Contact:
- Eugenio Stabile
- Telefoonnummer: +39 81 746 2228/53
- E-mail: eugeniostabile@gmail.com
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Carnaxide, Portugal
- Werving
- Hospital de Santa Cruz
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Contact:
- Rui Teles
- Telefoonnummer: +351 21 043 1000
- E-mail: rcteles@outlook.com
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A Coruña, Spanje
- Werving
- Hospital Universitario de a Coruna
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Contact:
- Dr Pablo Pinon
- Telefoonnummer: +34 981 17 80 00
- E-mail: info@jjphospitalaria.com
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Madrid, Spanje
- Werving
- Hospital Clínico San Carlos
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Contact:
- Dr.Luis Nombel
- Telefoonnummer: 91 330 30 00
- E-mail: gerent.hcsc@salud.madrid.org
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Valladolid, Spanje
- Werving
- Hospital clinico Universitario de Valladolid
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Contact:
- Dr. Filippo Pensotti
- Telefoonnummer: +34 983 42 00 00
- E-mail: ceim.asva@saludcastillayleon.esjalvarezgo
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Lucerne, Zwitserland
- Werving
- Luzerner Kantonsspital | Herzzentrum
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Contact:
- Dr.Stefan Toggweiler
- Telefoonnummer: 0412051111
- E-mail: ifo@luks.ch
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
Beschrijving
Inclusion Criteria:
- Subjects of age≥ 18 years
- Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
- Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements.
Exclusion Criteria:
- Pre-existing mechanical heart valve in aortic position
- A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
- Ongoing sepsis, including active endocarditis
- Anatomically not suitable for the VitaFlow Liberty TAV system
- LVEF<20%
- Estimated life expectancy of less than 12 months
- Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
- Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
- Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Eenarmig klinisch onderzoek
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Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System. Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Composite rate of all-cause mortality and stroke with disability
Tijdsspanne: 12 months post procedure
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Composite rate of all-cause mortality and stroke with disability |
12 months post procedure
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Safety outcomes defined by VARC3
Tijdsspanne: 30 days, 12 months, and 2-5 years post procedure
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Rate of all-cause mortality, myocardial infarction, stroke, implanted related new and/or worsen conduction disturbances and arrhythmias, new permanent pacemaker implantation, procedure-related or valve-related hospitalization defined by VARC 3. |
30 days, 12 months, and 2-5 years post procedure
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Safety outcomes defined by VARC3
Tijdsspanne: 30 days and 12 months post procedure
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Rate of type 2-4 bleeding, major vascular and access-related complications, acute kidney injury (stage 2-4) defined by VARC 3 |
30 days and 12 months post procedure
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Safety outcomes defined by VARC3
Tijdsspanne: acute procedure (within 24 hours)
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Rate of other acute procedural and technical valve related complications: conversion to surgery; unplanned use of mechanical circulatory support; implantation of multiple (>1) transcatheter valves during the index hospitalization; valve mal-position |
acute procedure (within 24 hours)
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Device success
Tijdsspanne: 30 days post implantation
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Device success defined by VARC 3 |
30 days post implantation
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Device early safety
Tijdsspanne: 30 days post implantation
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Device early safety defined by VARC 3 |
30 days post implantation
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Bioprosthesis haemodynamic function
Tijdsspanne: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2). |
Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function
Tijdsspanne: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function (assessed by echocardiography) including mean transvalvular gradient (mmHg). |
Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function
Tijdsspanne: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total). |
Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthetic valve dysfunction
Tijdsspanne: 12 months and 2-5 years post procedure
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Moderate or severe haemodynamic valve deterioration defined by VARC3 |
12 months and 2-5 years post procedure
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Bioprosthetic valve dysfunction
Tijdsspanne: 12 months and 2-5 years post procedure
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Bioprosthetic valve failure defined by VARC3 |
12 months and 2-5 years post procedure
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Bioprosthetic valve dysfunction
Tijdsspanne: 12 months and 2-5 years post procedure
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Clinically significant valve thrombosis defined by VARC3 |
12 months and 2-5 years post procedure
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NYHA Classification
Tijdsspanne: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
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Changes in cardiac function at discharge, 30 days and 12 months and 2-5 years post implantation according to the NYHA Classification Scheme compared to baseline |
From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
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Rate of Alwide Plus Balloon Catheter pre-dilation success
Tijdsspanne: During procedure
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Defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter |
During procedure
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Alwide Plus Balloon Catheter related adverse-event
Tijdsspanne: Discharge
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Discharge
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Predictors for the permanent pacemaker implantation
Tijdsspanne: Baseline or intraprocedure
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Including but not limited to pre-existing conduction disturbance, implant depth, LVOT calcium volume , post-dilatation |
Baseline or intraprocedure
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Darren Mylotte, MD, Galway University Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- VitaFlow EU-2024
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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