NCT03402724

Completed

Long-term Clinical and Echographic Follow-up (More Than 4 Ye...

University Hospital, Montpellier Source

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Other study identifiers

Sponsor study identifier

UF7570

Study Type

observational

Actual enrollment (reported)

178

Locations

1 country

Sites

1

Timeline

Study Start

January 31, 2018

Actual (reported)

Primary Completion

December 31, 2019

Actual (reported)

Study Completion

December 31, 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 178 participants
Study completion date: December 31, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 10, 2018
Actual (reported)
First Posted
January 18, 2018
Actual (reported)
Study Start
January 31, 2018
Actual (reported)
Primary Completion
December 31, 2019
Actual (reported)
Study Completion
December 31, 2019
Actual (reported)

Last Updated: April 3, 2020
Status Verified: April 2020
Last Update Submitted: April 2, 2020

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

echographicOther

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

University Hospital, Montpellier
Otherlead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Study Officials

Florence LECLERCQ
University Hospital, Montpellier
STUDY DIRECTOR

Enrollment

178 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.

Contact the study team to confirm eligibility.

Primary Completion

December 31, 2019

Actual (reported)

Study Completion

December 31, 2019

Actual (reported)

Last Updated

April 3, 2020

Record last verified: 2020-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03402724
Data provider: ClinicalTrials.gov
Source updated: 2020-04-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:03 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations