Severe and Symptomatic Aortic Stenosis Clinical Trial
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.
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02797158 -
Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study
|
N/A | |
| Completed |
NCT03865043 -
Vascular Complications and Bleeding After Transfemoral TAVI
|