Aortic Valve StenosisCCQNCT01852552
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
An observational study of Aortic Valve Stenosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- transcatheter aortic valve implantation and Aortic Valve Replacement
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 518 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Jan 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients undergoing TAVI or AVR for AS at participating centers during the period of enrollment
Who may be able to join
- 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
Who cannot join
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
About this study
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Keywords
- Aortic stenosis, Transcatheter aortic valve implantation, Aortic valve replacement, Costs, Cognitive function, Quality of life
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter aortic valve implantationDevice
Also called Edwards Sapien XT, Corevalve, Acurate-TA
Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
Aortic Valve ReplacementProcedure or surgery
Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter aortic valve implantation | All consecutive patients undergoing TAVI at participating centres during study period Receives: Device: transcatheter aortic valve implantation | |
| 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 Receives: Procedure: Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE)
Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement
Measured: baseline, 3-month, 12-month
Hospital Anxiety and Depression Scale (HADS)
Changes of emotional status after transcatheter aortic valve implantation and surgical aortic valve replacement
Measured: baseline, 3-month, 12-month
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Changes in quality of life after transcatheter aortic valve implantation and surgical aortic valve replacement
Measured: baseline, 3-month, 12-month
In-hospital costs
Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.
Measured: 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 (7)
Myocardial infarction
Incidence of myocardial infarction
Measured: 30-day, 12-month and up to 2-year (longest available follow-up)
Stroke
Incidence of stroke
Measured: 30-day, 12-month and up to 2-year (longest available follow-up)
Pace-maker implantation
Need for permanent pacing
Measured: 30-day, 12-month
Vascular complications
Incidence of vascular complications as defined by the VARC
Measured: 30-day
Bleedings
Incidence of bleedings as defined by the VARC
Measured: 30-day
Acute kidney injury
Incidence of AKI as defined by the VARC
Measured: 30-day
Follow-up costs
Evaluation of costs during follow-up, including new hospital admissions, outpatient clinic and drugs
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startDec 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 518 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy, Region Emilia-Romagna, Italy
- Responsible party
- Principal investigator, Francesco Saia, MD, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852552
- Sponsor's protocol ID
- GR-2009-1578270
- Acronym
- CCQ
- Status last verified
- Nov 2016
- First submitted
- 8 May 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT01852552
- Acronym / sponsor ID
- CCQ / GR-2009-1578270
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic stenosis, Transcatheter aortic valve implantation, Aortic valve replacement, Costs, Cognitive function, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy, Region Emilia-Romagna, Italy
- Study start
- Dec 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter aortic valve implantation | – | Device: transcatheter aortic valve implantationAll consecutive patients undergoing TAVI at participating centres during study period |
| Aortic Valve Replacement | – | Procedure: Aortic Valve ReplacementAll consecutive patients aged ≥ 80 years or with Logistic Euroscore≥ 15% undergoing AVR for AS at participating centers during the period of enrollment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients undergoing TAVI or AVR for AS at participating centers during the period of enrollment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcatheter aortic valve implantationAlso: Edwards Sapien XT, Corevalve, Acurate-TAPatients undergoing TAVI with transfemoral, transapical, or any other vascular access | Device | Transcatheter aortic valve implantation |
| Aortic Valve ReplacementSurgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical) | Procedure or surgery | Aortic Valve Replacement |
Primary outcome
Mini Mental State Examination (MMSE)
Time frame: baseline, 3-month, 12-month
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
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
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
Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Examination (MMSE) (time frame: baseline, 3-month, 12-month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.