- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01852552
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement (CCQ)
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
The objectives of the study are:
- Description of neurocognitive status before and after transcatheter aortic valve implantation and aortic valve replacement procedures
- Description of Quality of Life (QoL) after these procedures
- Defining the relevance of baseline psychological, emotional and cognitive factors on the outcomes associated to the different treatment modalities
- Assessment of costs associated to each of the above mentioned strategies of treatment, including costs of the index hospitalization and costs of follow-up.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In Italy, a nation-wide observational study endorsed by the Superior Institute of Health has been previously launched in order to evaluate appropriateness and effectiveness of aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) procedures: the OBservational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment (OBSERVANT). The present study was designed to complement the national survey on TAVI and AVR procedures including data about costs, cognitive functions and quality of life after these procedures. This integrated framework may help defining the relevance of baseline psychological, emotional and cognitive factors on the outcomes associated to the different treatment modalities and, on the other hand, should enable accurate evaluation of the impact of each kind of treatment on quality of life and neuropsychological functions. These elements could also represent relevant keys to decision-making to the different therapeutic strategies. In addition, we aim to ascertain costs associated to each of the above mentioned strategies of treatment, including costs of the index hospitalization and follow-up costs. Costs estimate, combined to the integrated physical and mental health status outcome for each treatment modality, may represent the background for subsequent cost-effectiveness analyses.
All consecutive patients undergoing transcatheter aortic valve implantation or aortic valve replacement (if age ≥ 80 years or Logistic Euroscore ≥ 15%) for aortic stenosis at participating centers during the period of enrollment will be included in the registry, after release of written informed consent. Allocation of patients to different treatment groups will be performed jointly by a cardiologist and a cardiac surgeon on the basis of a complete clinical framework, independently from the present study and in accordance with available guidelines. Type of treatment (for example, access site for TAVI, type of prosthesis…) will be decided by the physicians based on local clinical practice and general principles of good clinical practice.
The administration of neurocognitive and quality of life questionnaires will be performed before the procedure and after 3 months and 1 year by trained personnel following standard operation procedures defined by a coordinating unit. A telephone and web-based support for operators will be available throughout the entire duration of the study. A common methodology for data collection and analysis is defined to guarantee data reliability and homogeneity of assessments among the participating units. The cost analysis will be coordinated by the Regional Healthcare and Social Agency of the Emilia Romagna Region.
Data will be collected in a web-based database (OBSERVANT) through dedicated Case Records Forms and a final database will be built by merging this database with a separate database for costs and Hospital Discharge Records and Mortality Registry databases.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Bologna, Italie, 40138
- Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- All consecutive patients undergoing TAVI at participating centers during the period of enrollment
- All consecutive patients aged ≥80 years or with Logistic Euroscore ≥15% undergoing AVR at participating centers during the period of enrollment
Exclusion Criteria:
- Absence of informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Transcatheter aortic valve implantation
All consecutive patients undergoing TAVI at participating centres during study period
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Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
Autres noms:
|
Aortic Valve Replacement
All consecutive patients aged ≥ 80 years or with Logistic Euroscore≥ 15% undergoing AVR for AS at participating centers during the period of enrollment
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Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mini Mental State Examination (MMSE)
Délai: baseline, 3-month, 12-month
|
Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement
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baseline, 3-month, 12-month
|
Hospital Anxiety and Depression Scale (HADS)
Délai: baseline, 3-month, 12-month
|
Changes of emotional status after transcatheter aortic valve implantation and surgical aortic valve replacement
|
baseline, 3-month, 12-month
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Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Délai: baseline, 3-month, 12-month
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Changes in quality of life after transcatheter aortic valve implantation and surgical aortic valve replacement
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baseline, 3-month, 12-month
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In-hospital costs
Délai: Participants will be followed for the duration of hospital stay, an expected average of 10 days for transcatheter aortic valve implantation and 2 weeks for surgical Aortic Valve Replacement
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Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.
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Participants will be followed for the duration of hospital stay, an expected average of 10 days for transcatheter aortic valve implantation and 2 weeks for surgical Aortic Valve Replacement
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Myocardial infarction
Délai: 30-day, 12-month and up to 2-year (longest available follow-up)
|
Incidence of myocardial infarction
|
30-day, 12-month and up to 2-year (longest available follow-up)
|
Stroke
Délai: 30-day, 12-month and up to 2-year (longest available follow-up)
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Incidence of stroke
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30-day, 12-month and up to 2-year (longest available follow-up)
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Pace-maker implantation
Délai: 30-day, 12-month
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Need for permanent pacing
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30-day, 12-month
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Vascular complications
Délai: 30-day
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Incidence of vascular complications as defined by the VARC
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30-day
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Bleedings
Délai: 30-day
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Incidence of bleedings as defined by the VARC
|
30-day
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Acute kidney injury
Délai: 30-day
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Incidence of AKI as defined by the VARC
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30-day
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Follow-up costs
Délai: 12-month
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Evaluation of costs during follow-up, including new hospital admissions, outpatient clinic and drugs
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12-month
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GR-2009-1578270
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