Overview

This trial has been completed.

Condition aortic valve stenosis
Treatments transcatheter aortic valve implantation, aortic valve replacement
Sponsor Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Collaborator Ministry of Health, Italy
Start date December 2011
End date January 2016
Trial size 518 participants
Trial identifier NCT01852552, GR-2009-1578270

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All consecutive patients undergoing TAVI at participating centres during study period
transcatheter aortic valve implantation Edwards Sapien XT
Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
All consecutive patients aged ≥ 80 years or with Logistic Euroscore≥ 15% undergoing AVR for AS at participating centers during the period of enrollment
aortic valve replacement
Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)

Primary Outcomes

Measure
Mini Mental State Examination (MMSE)
time frame: baseline, 3-month, 12-month
Hospital Anxiety and Depression Scale (HADS)
time frame: baseline, 3-month, 12-month
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
time frame: baseline, 3-month, 12-month
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

Secondary Outcomes

Measure
Myocardial infarction
time frame: 30-day, 12-month and up to 2-year (longest available follow-up)
Stroke
time frame: 30-day, 12-month and up to 2-year (longest available follow-up)
Pace-maker implantation
time frame: 30-day, 12-month
Vascular complications
time frame: 30-day
Bleedings
time frame: 30-day
Acute kidney injury
time frame: 30-day
Follow-up costs
time frame: 12-month

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.