Severe and Symptomatic Aortic StenosisNCT03402724
Long-term Clinical and Echographic Follow-up (More Than 4 Years) After TAVI.
An observational study of Severe and Symptomatic Aortic Stenosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery. All studies assessed TAVI showed excellent results at short and mid-term follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe and Symptomatic Aortic Stenosis
- What is being tested?
- echographic
- How many people
- 178 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2018to 31 Dec 2019
- 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
- Adult, Older adult
Study population: All consecutive patients admitted from February 2010 to December 2014 at the University Hospital of Montpellier for the implantation of TAVI will be included for TAVI Edwards.
Who may be able to join
- All consecutive patients admitted from February 2010 to December 2014 at the University Hospital of Montpellier for the implantation of TAVI will be included for TAVI Edwards.
- Male or non-pregnant female ≥ 18 years without superior limit of age for TAVI, indicated for severe and sympto-matic aortic valve stenosis, defined according to the guidelines (1), with high-surgical risk or not suitable for surgery, and after Heart Team decision.
- Informed consent obtained at enrolment into the study
Who cannot join
- Inability to give informed consent or high likelihood of being unavailable for follow-up
- Patients died during the implantation and within one year after implantation will be excluded because of impossibil-ity of follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Clinical and Echographic Follow Up After TAVI: A Pro-spective Cohort Study.
Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery.
All studies assessed TAVI showed excellent results at short and mid-term follow-up. The current and future development of the devices predict an extension of indications to "intermediate-risk" and younger patients.
Read more
Therefore, long-term evaluation of these valves is a priority to determine their durability.
However, standardized echographic follow-up of patients implanted with TAVI is lacking.
Indeed, there was not consensual definition of TAVI degeneration until now. Recently, European Society of Cardiology published echographic criteria to precise and standardized TAVI deterioration based on simple hemodynamic and morphological criteria.
In addition, very few studies have been interested in monitoring more than 5 years of these devices.
Finally, nowadays we did not know if TAVI evolution is the same as surgical bioprosthesis.
Read the detailed description
Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery.
All studies assessed TAVI showed excellent results at short and mid-term follow-up. The current and future development of the devices predict an extension of indications to "intermediate-risk" and younger patients.
Therefore, long-term evaluation of these valves is a priority to determine their durability.
Clinical outcomes of these patients are well documented by large registers. Thus, FRANCE 2 registry studying more than 3000 patients realized in 34 French centers showed at 30 days a rate of death of 9.7%, and incidence of stroke of 3.4%. SOURCE registries studied more than 5000 patients in Europe and United-States with three generations of TAVI. All-cause mortality at 1 year was respectively 23.9%, 19.4% and 11.7% in SOURCE, SOURCE XT (Sapien XT) and SOURCE 3 (Sapien 3).
However, standardized echographic follow-up of patients implanted with TAVI is lacking.
Indeed, there was not consensual definition of TAVI degeneration until now. Recently, European Society of Cardiology published echographic criteria to precise and standardized TAVI deterioration based on simple hemodynamic and morphological criteria.
In addition, very few studies have been interested in monitoring more than 5 years of these devices.
Finally, nowadays the investigator did not know if TAVI evolution is the same as surgical bioprosthesis.
- Conditions
- Severe and Symptomatic Aortic Stenosis
- Being tested
- echographic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echographicOther
Patients are called for an echographic evaluation in the implanting center in case of the usual care
What is being measured
The primary outcome is the main question the study is designed to answer.
echographic follow-up
- echographic follow-up more than 4 years of TAVI implanted in CHU of Montpellier, using new echographic criteria defined by European Socizty of Cardiology
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start31 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe and Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence LECLERCQ, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402724
- Sponsor's protocol ID
- UF7570
- Status last verified
- Apr 2020
- First submitted
- 10 Jan 2018
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical and Echographic Follow Up After TAVI: A Pro-spective Cohort Study.
- ClinicalTrials.gov ID
- NCT03402724
- Acronym / sponsor ID
- UF7570
- Conditions
- Severe and Symptomatic Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jan 2018 (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.
Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery.
All studies assessed TAVI showed excellent results at short and mid-term follow-up. The current and future development of the devices predict an extension of indications to "intermediate-risk" and younger patients.
Therefore, long-term evaluation of these valves is a priority to determine their durability.
However, standardized echographic follow-up of patients implanted with TAVI is lacking.
Indeed, there was not consensual definition of TAVI degeneration until now. Recently, European Society of Cardiology published echographic criteria to precise and standardized TAVI deterioration based on simple hemodynamic and morphological criteria.
In addition, very few studies have been interested in monitoring more than 5 years of these devices.
Finally, nowadays we did not know if TAVI evolution is the same as surgical bioprosthesis.
Detailed description
Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery.
All studies assessed TAVI showed excellent results at short and mid-term follow-up. The current and future development of the devices predict an extension of indications to "intermediate-risk" and younger patients.
Therefore, long-term evaluation of these valves is a priority to determine their durability.
Clinical outcomes of these patients are well documented by large registers. Thus, FRANCE 2 registry studying more than 3000 patients realized in 34 French centers showed at 30 days a rate of death of 9.7%, and incidence of stroke of 3.4%. SOURCE registries studied more than 5000 patients in Europe and United-States with three generations of TAVI. All-cause mortality at 1 year was respectively 23.9%, 19.4% and 11.7% in SOURCE, SOURCE XT (Sapien XT) and SOURCE 3 (Sapien 3).
However, standardized echographic follow-up of patients implanted with TAVI is lacking.
Indeed, there was not consensual definition of TAVI degeneration until now. Recently, European Society of Cardiology published echographic criteria to precise and standardized TAVI deterioration based on simple hemodynamic and morphological criteria.
In addition, very few studies have been interested in monitoring more than 5 years of these devices.
Finally, nowadays the investigator did not know if TAVI evolution is the same as surgical bioprosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted from February 2010 to December 2014 at the University Hospital of Montpellier for the implantation of TAVI will be included for TAVI Edwards.
Key inclusion criteria (3 listed)
- All consecutive patients admitted from February 2010 to December 2014 at the University Hospital of Montpellier for the implantation of TAVI will be included for TAVI Edwards.
- Male or non-pregnant female ≥ 18 years without superior limit of age for TAVI, indicated for severe and sympto-matic aortic valve stenosis, defined according to the guidelines (1), with high-surgical risk or not suitable for surgery, and after Heart Team decision.
- Informed consent obtained at enrolment into the study
Key exclusion criteria (2 listed)
- Inability to give informed consent or high likelihood of being unavailable for follow-up
- Patients died during the implantation and within one year after implantation will be excluded because of impossibil-ity of 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 |
|---|---|---|
| echographicPatients are called for an echographic evaluation in the implanting center in case of the usual care | Other | – |
Primary outcome
echographic follow-up
Time frame: 1 day
- echographic follow-up more than 4 years of TAVI implanted in CHU of Montpellier, using new echographic criteria defined by European Socizty of Cardiology
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 3 Apr 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Florence LECLERCQ study director
University Hospital, Montpellier
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 Severe and Symptomatic Aortic Stenosis, run by University Hospital, Montpellier 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 3 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 3 Apr 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?
echographic follow-up (time frame: 1 day). 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 3 Apr 2020.