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Trial record 8 of 371 for:    aortic valve replacement

Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement (CCQ)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Italy
Region Emilia-Romagna, Italy
Information provided by (Responsible Party):
Francesco Saia, MD, PhD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01852552
First received: May 8, 2013
Last updated: November 11, 2016
Last verified: November 2016
  Purpose

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:

  1. Description of neurocognitive status before and after transcatheter aortic valve implantation and aortic valve replacement procedures
  2. Description of Quality of Life (QoL) after these procedures
  3. Defining the relevance of baseline psychological, emotional and cognitive factors on the outcomes associated to the different treatment modalities
  4. Assessment of costs associated to each of the above mentioned strategies of treatment, including costs of the index hospitalization and costs of follow-up.

Condition Intervention
Aortic Valve Stenosis
Device: transcatheter aortic valve implantation
Procedure: Aortic Valve Replacement

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Mini Mental State Examination (MMSE) [ Time Frame: baseline, 3-month, 12-month ] [ Designated as safety issue: No ]
    Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: baseline, 3-month, 12-month ] [ Designated as safety issue: No ]
    Changes of emotional status after transcatheter aortic valve implantation and surgical aortic valve replacement

  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: baseline, 3-month, 12-month ] [ Designated as safety issue: No ]
    Changes in quality of life after transcatheter aortic valve implantation and surgical aortic valve replacement

  • In-hospital costs [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.


Secondary Outcome Measures:
  • Myocardial infarction [ Time Frame: 30-day, 12-month and up to 2-year (longest available follow-up) ] [ Designated as safety issue: No ]
    Incidence of myocardial infarction

  • Stroke [ Time Frame: 30-day, 12-month and up to 2-year (longest available follow-up) ] [ Designated as safety issue: No ]
    Incidence of stroke

  • Pace-maker implantation [ Time Frame: 30-day, 12-month ] [ Designated as safety issue: No ]
    Need for permanent pacing

  • Vascular complications [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    Incidence of vascular complications as defined by the VARC

  • Bleedings [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    Incidence of bleedings as defined by the VARC

  • Acute kidney injury [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    Incidence of AKI as defined by the VARC

  • Follow-up costs [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    Evaluation of costs during follow-up, including new hospital admissions, outpatient clinic and drugs


Enrollment: 518
Study Start Date: December 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Transcatheter aortic valve implantation
All consecutive patients undergoing TAVI at participating centres during study period
Device: transcatheter aortic valve implantation
Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
Other Names:
  • Edwards Sapien XT
  • Corevalve
  • Acurate-TA
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
Procedure: Aortic Valve Replacement
Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients undergoing TAVI or AVR for AS at participating centers during the period of enrollment
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852552

Locations
Italy
Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Ministry of Health, Italy
Region Emilia-Romagna, Italy
  More Information

Responsible Party: Francesco Saia, MD, PhD, Dr., Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01852552     History of Changes
Other Study ID Numbers: GR-2009-1578270 
Study First Received: May 8, 2013
Last Updated: November 11, 2016
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Aortic stenosis
Transcatheter aortic valve implantation
Aortic valve replacement
Costs
Cognitive function
Quality of life

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on December 09, 2016