Aortic StenosisTAVI-GeriatrieNCT04564534
Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
An observational study of Aortic Stenosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- MoCA cognitive assessment
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2019to 30 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic stenosis and a confirmed indication for TAVI, scheduled to undergo TAVI and who perform their pre-TAVI work-up in our centre will be invited to participate.
Who may be able to join
- Aged 18 years or over
- Scheduled to undergo TAVI
- Provide informed consent
- Able to understand French
Who cannot join
- subjects under legal guardianship or other legal protection
- subjects with documented severe dementia
- subjects with anticipated poor compliance
- subjects unable to understand French sufficiently well to perform the MoCA test
- pregnant women
- subjects within the exclusion period of another study
Trial locations and contacts
1 site in 1 country.
About this study
This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).
Read the detailed description
This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)
- Conditions
- Aortic Stenosis
- Being tested
- MoCA cognitive assessment
- Keywords
- transcatheter aortic valve replacement, aortic stenosis, cognitive status
- 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.
MoCA cognitive assessmentOther
cognitive assessment using the validated MoCA test administered via an application on an iPad
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Adult (>18 years) patients with aortic stenosis in whom TAVI is planned and who perform their pre-TAVI work-up in our centre will be invited to undergo cognitive assessment using the MoCA at the time of their hospitalization for pre-TAVI work-up.
The MoCA will be administered by trained professionals with MoCA certification.
Clinical outcomes, as assessed by the VARC2 criteria, will be collected for all patients at 3 months after the TAVI procedure. Receives: Other: MoCA cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death
Measured: through 30 days after the TAVI procedure
Stroke
Safety outcome at 30 days as assessed by the VARC2 criteria: stroke
Measured: through 30 days after the TAVI procedure
life-threatening bleed
Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed
Measured: through 30 days after the TAVI procedure
Combined VARC2 safety outcome
Safety criteria (within 30 days of the procedure) include all-cause death; stroke; life-threatening bleed; renal insufficiency; coronary artery obstruction requiring intervention; major vascular complication; valve dysfunction.
Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-rela
Measured: through 30 days after the TAVI procedure
Combined VARC2 efficacy outcome
Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-related symptoms or worsening heart failure; NYHA Class III or IV; valve-related dysfunction.
Measured: through 30 days after the TAVI procedure
Secondary outcomes (3)
Time required for MoCA
Length of time required to administer the MoCA test using a tablet
Measured: At the time of MoCA completion
Biological parameters pre-procedure
Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.
Measured: pre-procedure
Relationship between MoCA score and each component of the VARC2
The relationship between the MoCA and each individual component of the VARC2 will be investigated in bivariable analysis.
Measured: At 3 months after TAVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start9 Oct 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Schiele, MD, PhD, Principal investigator, CHRU Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564534
- Sponsor's protocol ID
- P/2019/417
- Acronym
- TAVI-Geriatrie
- Status last verified
- Feb 2022
- First submitted
- 20 Jun 2019
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04564534
- Acronym / sponsor ID
- TAVI-Geriatrie / P/2019/417
- Conditions
- Aortic Stenosis
- Keywords
- transcatheter aortic valve replacement, aortic stenosis, cognitive status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- 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.
This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).
Detailed description
This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: MoCA cognitive assessmentAdult (>18 years) patients with aortic stenosis in whom TAVI is planned and who perform their pre-TAVI work-up in our centre will be invited to undergo cognitive assessment using the MoCA at the time of their hospitalization for pre-TAVI work-up. The MoCA will be administered by trained professionals with MoCA certification. Clinical outcomes, as assessed by the VARC2 criteria, will be collected for all patients at 3 months after the TAVI procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic stenosis and a confirmed indication for TAVI, scheduled to undergo TAVI and who perform their pre-TAVI work-up in our centre will be invited to participate.
Key inclusion criteria (4 listed)
- Aged 18 years or over
- Scheduled to undergo TAVI
- Provide informed consent
- Able to understand French
Key exclusion criteria (6 listed)
- subjects under legal guardianship or other legal protection
- subjects with documented severe dementia
- subjects with anticipated poor compliance
- subjects unable to understand French sufficiently well to perform the MoCA test
- pregnant women
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 |
|---|---|---|
| MoCA cognitive assessmentcognitive assessment using the validated MoCA test administered via an application on an iPad | Other | Study cohort |
Primary outcome
All-cause death
Time frame: through 30 days after the TAVI procedure
Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death
Stroke
Time frame: through 30 days after the TAVI procedure
Safety outcome at 30 days as assessed by the VARC2 criteria: stroke
life-threatening bleed
Time frame: through 30 days after the TAVI procedure
Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed
Combined VARC2 safety outcome
Time frame: through 30 days after the TAVI procedure
Safety criteria (within 30 days of the procedure) include all-cause death; stroke; life-threatening bleed; renal insufficiency; coronary artery obstruction requiring intervention; major vascular complication; valve dysfunction. Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-rela
Combined VARC2 efficacy outcome
Time frame: through 30 days after the TAVI procedure
Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-related symptoms or worsening heart failure; NYHA Class III or IV; valve-related dysfunction.
3 secondary outcomes
Time required for MoCA
Time frame: At the time of MoCA completion
Biological parameters pre-procedure
Time frame: pre-procedure
Relationship between MoCA score and each component of the VARC2
Time frame: At 3 months after TAVI procedure
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 24 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Francois Schiele, MD, PhD principal investigator
CHRU Besancon
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 Stenosis, run by Centre Hospitalier Universitaire de Besancon 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 4 inclusion and 6 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 24 Feb 2022. 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?
All-cause death (time frame: through 30 days after the TAVI procedure). The study lists 5 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 24 Feb 2022.