NCT03402724

Long-term Clinical and Echographic Follow-up (More Than 4 Years) After TAVI.

Long Term Clinical and Echographic Follow Up After TAVI: A Pro-spective Cohort Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 178 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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. 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.

Conditions

• Severe and Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
OTHER	echographic	Patients are called for an echographic evaluation in the implanting center in case of the usual care

Timeline

• Start date: 2018-01-31
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-01-18
• Last updated: 2020-04-03

Locations

1 site across 1 country: France