Aortic Valve StenosisCGA-TAVINCT01991444
CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 3 sites in 3 countries.
Trial summary
Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation. It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- TAVI
- How many people
- 72 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2014to Feb 2017
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites. Routine data about the invervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected.
Who may be able to join
- Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
- Compliance with the indications of the instructions for use
- Age of at least 80 years
- Written informed consent
Who cannot join
- Presence of contraindications as to the Instructions for Use
- No possibility for a follow-up
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.
Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation.
It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve Implantation in elderly ( > 80 years) Patient. Possible participants are all Patient of 80 years or above for whom the implantation of a Edwards Sapien XT aortic valve is planned
Read the detailed description
Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment
- Conditions
- Aortic Valve Stenosis
- Being tested
- TAVI
- 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.
TAVIOther
no Intervention planned, Observation only
| Study group | Role | What they receive |
|---|---|---|
| TAVI patients of > 79 years | All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites.
Routine data about the intervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected. Receives: Other: TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive geriatric assessment
Demonstrate CGA changes within 3 months after TAVI
The CGA is an array of several different assessments with regard to frailty, comorbidities, administrative data (Silver code), Quality of life etc. Every Patient will undergo a CGA at baseline and 3 months after TAVI. Data will be analyzed to determine changes in CGA results.
Measured: Baseline and 3 months
Secondary outcomes (2)
predictive Value of CGA Tavi
Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission
Measured: baseline
Score development
Development of a comprehensive score for the assessment of TAVI patient prognosis (identifying variables from the MPI, SPPB and SilverCode that account for 80% of the predictive power of the complete set)
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andrea Ungar, MD, Principal investigator, Geriatric Cardiology and Medicine - U. of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991444
- Sponsor's protocol ID
- U1111-1149-9951
- Other IDs
- DRKS00005436
- Acronym
- CGA-TAVI
- Status last verified
- Apr 2017
- First submitted
- 7 Nov 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ungar A, Mannarino G, van der Velde N, Baan J, Thibodeau MP, Masson JB, Santoro G, van Mourik M, Jansen S, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Maggi S, Schoenenberger AW. Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry. BMC Cardiovasc Disord. 2018 Jan 4;18(1):1. doi: 10.1186/s12872-017-0740-x.
PubMed 29301486
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.
- ClinicalTrials.gov ID
- NCT01991444
- Acronym / sponsor ID
- CGA-TAVI / U1111-1149-9951
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Nov 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.
Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation.
It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve Implantation in elderly ( > 80 years) Patient. Possible participants are all Patient of 80 years or above for whom the implantation of a Edwards Sapien XT aortic valve is planned
Detailed description
Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI patients of > 79 years | – | Other: TAVIAll patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites. Routine data about the intervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites. Routine data about the invervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected.
Key inclusion criteria (4 listed)
- Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
- Compliance with the indications of the instructions for use
- Age of at least 80 years
- Written informed consent
Key exclusion criteria (2 listed)
- Presence of contraindications as to the Instructions for Use
- No possibility for a follow-up
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 |
|---|---|---|
| TAVIno Intervention planned, Observation only | Other | TAVI patients of > 79 years |
Primary outcome
Comprehensive geriatric assessment
Time frame: Baseline and 3 months
Demonstrate CGA changes within 3 months after TAVI The CGA is an array of several different assessments with regard to frailty, comorbidities, administrative data (Silver code), Quality of life etc. Every Patient will undergo a CGA at baseline and 3 months after TAVI. Data will be analyzed to determine changes in CGA results.
2 secondary outcomes
predictive Value of CGA Tavi
Time frame: baseline
Score development
Time frame: after 3 months
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 5 Apr 2017.
- Derived from this study: PubMed 29301486Ungar A, Mannarino G, van der Velde N, Baan J, Thibodeau MP, Masson JB, Santoro G, van Mourik M, Jansen S, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Maggi S, Schoenenberger AW. Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry. BMC Cardiovasc Disord. 2018 Jan 4;18(1):1. doi: 10.1186/s12872-017-0740-x.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Valve Stenosis
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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Andrea Ungar, MD principal investigator
Geriatric Cardiology and Medicine - U. of Florence
3 sites in 3 countries: 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 Institut für Pharmakologie und Präventive Medizin at 3 sites in 3 countries.
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 4 inclusion and 2 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Italy, Netherlands. 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?
Comprehensive geriatric assessment (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991444, which also lists 1 linked publication.
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 5 Apr 2017.