VitaFlow LIBERTÉ Europe
Étude de suivi clinique post-commercialisation du système de valve aortique transcathéter VitaFlow Liberty™
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zhujun Cai, PhD
- Numéro de téléphone: 86-021-38954600
- E-mail: zjcai@microport.com
Sauvegarde des contacts de l'étude
- Nom: Yann Poezevara, PhD
- Numéro de téléphone: 0033-146013409
- E-mail: Yann.Poezevara@cf.microport.com
Lieux d'étude
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A Coruña, Espagne
- Recrutement
- Hospital Universitario de a Coruna
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Contact:
- Dr Pablo Pinon
- Numéro de téléphone: +34 981 17 80 00
- E-mail: info@jjphospitalaria.com
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Madrid, Espagne
- Recrutement
- Hospital Clínico San Carlos
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Contact:
- Dr.Luis Nombel
- Numéro de téléphone: 91 330 30 00
- E-mail: gerent.hcsc@salud.madrid.org
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Valladolid, Espagne
- Recrutement
- Hospital clinico Universitario de Valladolid
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Contact:
- Dr. Filippo Pensotti
- Numéro de téléphone: +34 983 42 00 00
- E-mail: ceim.asva@saludcastillayleon.esjalvarezgo
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Galway, Irlande
- Recrutement
- Galway University Hospital
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Contact:
- Darren Mylotte, MD
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Castel Volturno, Italie
- Recrutement
- Pineta Grande Hospital
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Contact:
- Alberto Morello
- Numéro de téléphone: +393397904191
- E-mail: albertomorello83@gmail.com
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Pisa, Italie
- Recrutement
- Ospedale Cisanello
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Contact:
- Dr.Marco De Carlo
- Numéro de téléphone: +39 050 971 9530
- E-mail: urp@ao-pisa.toscana.it
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Potenza, Italie
- Recrutement
- Azienda Ospedaliera Regionale -S.Carlo
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Contact:
- Eugenio Stabile
- Numéro de téléphone: +39 81 746 2228/53
- E-mail: eugeniostabile@gmail.com
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Carnaxide, Le Portugal
- Recrutement
- Hospital de Santa Cruz
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Contact:
- Rui Teles
- Numéro de téléphone: +351 21 043 1000
- E-mail: rcteles@outlook.com
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Lucerne, Suisse
- Recrutement
- Luzerner Kantonsspital | Herzzentrum
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Contact:
- Dr.Stefan Toggweiler
- Numéro de téléphone: 0412051111
- E-mail: ifo@luks.ch
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Investigation clinique à un seul bras
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Composite rate of all-cause mortality and stroke with disability
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Safety outcomes defined by VARC3
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Discharge
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Discharge
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Predictors for the permanent pacemaker implantation
Délai: 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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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Darren Mylotte, MD, Galway University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VitaFlow EU-2024
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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