VitaFlow LIBERTY Europe
VitaFlow Liberty™ Transkateter aortaklaffsystem Klinisk uppföljningsstudie efter marknadsintroduktion
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Zhujun Cai, PhD
- Telefonnummer: 86-021-38954600
- E-post: zjcai@microport.com
Studera Kontakt Backup
- Namn: Yann Poezevara, PhD
- Telefonnummer: 0033-146013409
- E-post: Yann.Poezevara@cf.microport.com
Studieorter
-
-
-
Galway, Irland
- Rekrytering
- Galway University Hospital
-
Kontakt:
- Darren Mylotte, MD
-
-
-
-
-
Castel Volturno, Italien
- Rekrytering
- Pineta Grande Hospital
-
Kontakt:
- Alberto Morello
- Telefonnummer: +393397904191
- E-post: albertomorello83@gmail.com
-
Pisa, Italien
- Rekrytering
- Ospedale Cisanello
-
Kontakt:
- Dr.Marco De Carlo
- Telefonnummer: +39 050 971 9530
- E-post: urp@ao-pisa.toscana.it
-
Potenza, Italien
- Rekrytering
- Azienda Ospedaliera Regionale -S.Carlo
-
Kontakt:
- Eugenio Stabile
- Telefonnummer: +39 81 746 2228/53
- E-post: eugeniostabile@gmail.com
-
-
-
-
-
Carnaxide, Portugal
- Rekrytering
- Hospital de Santa Cruz
-
Kontakt:
- Rui Teles
- Telefonnummer: +351 21 043 1000
- E-post: rcteles@outlook.com
-
-
-
-
-
Lucerne, Schweiz
- Rekrytering
- Luzerner Kantonsspital | Herzzentrum
-
Kontakt:
- Dr.Stefan Toggweiler
- Telefonnummer: 0412051111
- E-post: ifo@luks.ch
-
-
-
-
-
A Coruña, Spanien
- Rekrytering
- Hospital Universitario de a Coruna
-
Kontakt:
- Dr Pablo Pinon
- Telefonnummer: +34 981 17 80 00
- E-post: info@jjphospitalaria.com
-
Madrid, Spanien
- Rekrytering
- Hospital Clínico San Carlos
-
Kontakt:
- Dr.Luis Nombel
- Telefonnummer: 91 330 30 00
- E-post: gerent.hcsc@salud.madrid.org
-
Valladolid, Spanien
- Rekrytering
- Hospital clinico Universitario de Valladolid
-
Kontakt:
- Dr. Filippo Pensotti
- Telefonnummer: +34 983 42 00 00
- E-post: ceim.asva@saludcastillayleon.esjalvarezgo
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Enarms klinisk undersökning
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Composite rate of all-cause mortality and stroke with disability
Tidsram: 12 months post procedure
|
Composite rate of all-cause mortality and stroke with disability |
12 months post procedure
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety outcomes defined by VARC3
Tidsram: 30 days, 12 months, and 2-5 years post procedure
|
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
|
|
Safety outcomes defined by VARC3
Tidsram: 30 days and 12 months post procedure
|
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
|
|
Safety outcomes defined by VARC3
Tidsram: acute procedure (within 24 hours)
|
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)
|
|
Device success
Tidsram: 30 days post implantation
|
Device success defined by VARC 3 |
30 days post implantation
|
|
Device early safety
Tidsram: 30 days post implantation
|
Device early safety defined by VARC 3 |
30 days post implantation
|
|
Bioprosthesis haemodynamic function
Tidsram: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
|
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
|
|
Bioprosthesis haemodynamic function
Tidsram: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
|
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
|
|
Bioprosthesis haemodynamic function
Tidsram: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
|
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
|
|
Bioprosthetic valve dysfunction
Tidsram: 12 months and 2-5 years post procedure
|
Moderate or severe haemodynamic valve deterioration defined by VARC3 |
12 months and 2-5 years post procedure
|
|
Bioprosthetic valve dysfunction
Tidsram: 12 months and 2-5 years post procedure
|
Bioprosthetic valve failure defined by VARC3 |
12 months and 2-5 years post procedure
|
|
Bioprosthetic valve dysfunction
Tidsram: 12 months and 2-5 years post procedure
|
Clinically significant valve thrombosis defined by VARC3 |
12 months and 2-5 years post procedure
|
|
NYHA Classification
Tidsram: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
|
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
|
|
Rate of Alwide Plus Balloon Catheter pre-dilation success
Tidsram: During procedure
|
Defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter |
During procedure
|
|
Alwide Plus Balloon Catheter related adverse-event
Tidsram: Discharge
|
Discharge
|
|
|
Predictors for the permanent pacemaker implantation
Tidsram: Baseline or intraprocedure
|
Including but not limited to pre-existing conduction disturbance, implant depth, LVOT calcium volume , post-dilatation |
Baseline or intraprocedure
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Darren Mylotte, MD, Galway University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VitaFlow EU-2024
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .