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

NCT03402724 | Completed

• 1 other identifier: UF7570
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Interventions

echographic OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• Florence LECLERCQ

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: January 31, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

FR (1)