Symptomatic Aortic StenosisEVA-G-TAVINCT02424370
Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation
An observational study of Symptomatic Aortic Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Symptomatic Aortic Stenosis
- What is being tested?
- TAVR
- Type of treatment
- Surgery or procedure
- How many people
- 515 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2015to 23 Jan 2020
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: person aged over 75 years with indication for implantation of TAVI
Who may be able to join
- Age ≥75
- Symptomatic aortic stenosis
- Prior geriatric evaluation
- Patient who agreed to answer the telephone follow-up to 6, 9 and 12 months
- Patient given his non-opposition to using his data
- Patient affiliated to the French social security.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cardiologie-GH Pitié Salpétirère
Paris, Île-de-France Region, 75013
About this study
Official title: Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation. Multicenter Observational Study
Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. The aim of the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and functional recovery after TAVR
Read the detailed description
Primary objective: identify geriatric biomarkers associated with vital/functional status after TAVR.
Primary outcome measure is altered functional status at six month follow-up defined as an absolute decrease of 15 points of the Barthel Index.
Secondary outcome measures are: Barthel index and survival at 6, 9 and 12 months follow-up. QOL during follow-up
- Conditions
- Symptomatic Aortic Stenosis
- Being tested
- TAVR
- Keywords
- Aortic stenosis, TAVR, Frailty, Elderly
- Medical subject headings
- Aortic Valve Stenosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVRProcedure or surgery
Also called Trans-aortic Valve Replacement
Percutaneous aortic valve replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months
Measured: at 6 months
Secondary outcomes (4)
Score of Barthel
Maintaining of the same Score
Measured: at 6, 9 and 12 months
Maintain or improve the quality of life score at 6 months, defined as a score of SF-12 scale at 6 months
Measured: at 6 months
Survival rate at 6 months, 9 months, 12 months
Measured: at 6, 9 and 12 months
Survival time after TAVI during the study
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study start9 Dec 2015
- Primary completion18 Sep 2018
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Joël BELMIN, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisJean Philippe COLLET, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424370
- Sponsor's protocol ID
- NI11069
- Acronym
- EVA-G-TAVI
- Status last verified
- Mar 2020
- First submitted
- 20 Apr 2015
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation. Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT02424370
- Acronym / sponsor ID
- EVA-G-TAVI / NI11069
- Conditions
- Symptomatic Aortic Stenosis
- Keywords
- Aortic stenosis, TAVR, Frailty, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 23 Apr 2015 (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.
Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. The aim of the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and functional recovery after TAVR
Detailed description
Primary objective: identify geriatric biomarkers associated with vital/functional status after TAVR.
Primary outcome measure is altered functional status at six month follow-up defined as an absolute decrease of 15 points of the Barthel Index.
Secondary outcome measures are: Barthel index and survival at 6, 9 and 12 months follow-up. QOL during follow-up
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- person aged over 75 years with indication for implantation of TAVI
Key inclusion criteria (6 listed)
- Age ≥75
- Symptomatic aortic stenosis
- Prior geriatric evaluation
- Patient who agreed to answer the telephone follow-up to 6, 9 and 12 months
- Patient given his non-opposition to using his data
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TAVRAlso: Trans-aortic Valve ReplacementPercutaneous aortic valve replacement | Procedure or surgery | – |
Primary outcome
Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months
Time frame: at 6 months
4 secondary outcomes
Score of Barthel
Time frame: at 6, 9 and 12 months
Maintain or improve the quality of life score at 6 months, defined as a score of SF-12 scale at 6 months
Time frame: at 6 months
Survival rate at 6 months, 9 months, 12 months
Time frame: at 6, 9 and 12 months
Survival time after TAVI during the study
Time frame: up to 30 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 12 Oct 2020.
Related trials for Symptomatic Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Symptomatic Hypertrophic Cardiomyopathy (HCM)
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.
Joël BELMIN, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Jean Philippe COLLET, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Symptomatic Aortic Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 0 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 12 Oct 2020. 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 France. 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?
Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months (time frame: at 6 months). 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 12 Oct 2020.