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

NCT03402724 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 178

Last updated 2020-04-03

No results posted yet for this study

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.

Conditions

  • Severe and Symptomatic Aortic Stenosis

Interventions

OTHER

echographic

Patients are called for an echographic evaluation in the implanting center in case of the usual care

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Florence LECLERCQ · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03402724 on ClinicalTrials.gov