- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Bologna, Italien, 40138
- Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Transcatheter aortic valve implantation
All consecutive patients undergoing TAVI at participating centres during study period
|
Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
Andre navne:
|
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
|
Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mini Mental State Examination (MMSE)
Tidsramme: baseline, 3-month, 12-month
|
Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement
|
baseline, 3-month, 12-month
|
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: baseline, 3-month, 12-month
|
Changes of emotional status after transcatheter aortic valve implantation and surgical aortic valve replacement
|
baseline, 3-month, 12-month
|
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Tidsramme: baseline, 3-month, 12-month
|
Changes in quality of life after transcatheter aortic valve implantation and surgical aortic valve replacement
|
baseline, 3-month, 12-month
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In-hospital costs
Tidsramme: 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
|
Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Myocardial infarction
Tidsramme: 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
Tidsramme: 30-day, 12-month and up to 2-year (longest available follow-up)
|
Incidence of stroke
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30-day, 12-month and up to 2-year (longest available follow-up)
|
Pace-maker implantation
Tidsramme: 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
Tidsramme: 30-day
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Incidence of vascular complications as defined by the VARC
|
30-day
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Bleedings
Tidsramme: 30-day
|
Incidence of bleedings as defined by the VARC
|
30-day
|
Acute kidney injury
Tidsramme: 30-day
|
Incidence of AKI as defined by the VARC
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30-day
|
Follow-up costs
Tidsramme: 12-month
|
Evaluation of costs during follow-up, including new hospital admissions, outpatient clinic and drugs
|
12-month
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GR-2009-1578270
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