Heart DiseaseC4CAPRINCT02935491
4 Cities for Assessing CAlcification PRognostic Impact After TAVI
An observational study of Heart Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure. Despite a high rate of procedural success, some patients do not benefit from the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Medical device
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Mar 2017
- 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 of both sex presenting with a severe aortic stenosis with the indication of aortic replacement by TAVI
Who may be able to join
- Age > 18
- Patient who underwent a transcatheter aortic valve implantation
- Patient who provided informed, written consent to participate to FRANCE TAVI study
- Patient for whom a CT-Scan performed before TAVI procedure is available.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure. Despite a high rate of procedural success, some patients do not benefit from the procedure. The investigators hypothesis is that aortic stiffness may be of major prognostic significance after stenosis relief.
The aim of this study is to test the prognostic impact of aortic stiffness estimated by the volume of calcifications of the thoracic aorta on the CT-scan performed systematically before the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4 french cities (Lyon, Rouen, Paris, Clermont-Ferrand).
- Conditions
- Heart Disease
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- TAVI, Aortic stenosis, aortic stiffness, calcifications, CT-scan, Vascular impedance
- Medical subject headings
- Heart Diseases, Aortic Valve Stenosis, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Device
TAVI is a well-accepted method for aortic valve replacement without surgery. It is currently proposed to patients at high surgical risk or contraindicated to surgery. It consists of introducing a valve inserted inside a stent by the femoral artery in most cases.
Aortic calcifications will be determined by the analysis of the CT-scan performed systematically before the procedure. A semi-automated software (CreaTools) will be used
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Implantation | Lyon and Paris cohorts : 900 patients will be used to test the prognostic value of aortic calcifications and to propose a risk score Clermont and Rouen cohorts (700 patients) will be used to test in an independent group, the predictive value of the risk score Receives: Device: Transcatheter Aortic Valve Implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Number of death of cardiovascular cause will be analyzed
Measured: censored on 3 March 2017
Secondary outcomes (4)
All-cause deaths
Number of death of all causes will be analyzed
Measured: censored on 3 March 2017
left ventricular remodeling
Echocardiographic measure will be done
Measured: censored on 3 March 2017
left ventricular ejection fraction
Echocardiographic measure will be done
Measured: censored on 3 March 2017
diastolic function
Echocardiographic measure will be done
Measured: censored on 3 March 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935491
- Sponsor's protocol ID
- 69HCL16_0651
- Acronym
- C4CAPRI
- Status last verified
- Mar 2017
- First submitted
- 14 Oct 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4 Cities for Assessing CAlcification PRognostic Impact After TAVI
- ClinicalTrials.gov ID
- NCT02935491
- Acronym / sponsor ID
- C4CAPRI / 69HCL16_0651
- Conditions
- Heart Disease
- Keywords
- TAVI, Aortic stenosis, aortic stiffness, calcifications, CT-scan, Vascular impedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Oct 2016 (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.
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure. Despite a high rate of procedural success, some patients do not benefit from the procedure. The investigators hypothesis is that aortic stiffness may be of major prognostic significance after stenosis relief.
The aim of this study is to test the prognostic impact of aortic stiffness estimated by the volume of calcifications of the thoracic aorta on the CT-scan performed systematically before the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4 french cities (Lyon, Rouen, Paris, Clermont-Ferrand).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Implantation | – | Device: Transcatheter Aortic Valve Implantation (TAVI)Lyon and Paris cohorts : 900 patients will be used to test the prognostic value of aortic calcifications and to propose a risk score Clermont and Rouen cohorts (700 patients) will be used to test in an independent group, the predictive value of the risk score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sex presenting with a severe aortic stenosis with the indication of aortic replacement by TAVI
Key inclusion criteria (4 listed)
- Age > 18
- Patient who underwent a transcatheter aortic valve implantation
- Patient who provided informed, written consent to participate to FRANCE TAVI study
- Patient for whom a CT-Scan performed before TAVI procedure is available.
Key exclusion criteria (1 listed)
- none
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 Implantation (TAVI)TAVI is a well-accepted method for aortic valve replacement without surgery. It is currently proposed to patients at high surgical risk or contraindicated to surgery. It consists of introducing a valve inserted inside a stent by the femoral artery in most cases. Aortic calcifications will be determined by the analysis of the CT-scan performed systematically before the procedure. A semi-automated software (CreaTools) will be used | Device | Transcatheter Aortic Valve Implantation |
Primary outcome
Cardiovascular mortality
Time frame: censored on 3 March 2017
Number of death of cardiovascular cause will be analyzed
4 secondary outcomes
All-cause deaths
Time frame: censored on 3 March 2017
left ventricular remodeling
Time frame: censored on 3 March 2017
left ventricular ejection fraction
Time frame: censored on 3 March 2017
diastolic function
Time frame: censored on 3 March 2017
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 13 Mar 2017.
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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 Heart Disease, run by Hospices Civils de Lyon 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 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 13 Mar 2017. 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?
Cardiovascular mortality (time frame: censored on 3 March 2017). 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 13 Mar 2017.