Uhmontpellier
Montpellier, 34295, France
NCT Number: NCT03402724
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Montpellier, 34295, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are called for an echographic evaluation in the implanting center in case of the usual care
Time frame: 1 day
University Hospital, Montpellier
Other
Long Term Clinical and Echographic Follow Up After TAVI: A Pro-spective Cohort Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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