5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI Trial
NCT ID: NCT05140317
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
236 participants
OBSERVATIONAL
2021-05-01
2023-08-01
Brief Summary
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Detailed Description
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A systematic echographic follow-up will be performed in all patients enrolled in the DIRECTAVI trial at the longest follow -up obtained after TAVR between 2021 and 2022. Clinical follow-up will be obtained with a brief patient clinical questionnaire or by phone by patients' cardiologist.
Serial Echographic follow-up will be obtained by patients' cardiologist except for the latest follow-up echocardiography (primary end point) performed in the reference center at Montpellier University hospital by two experienced cardiologists specialized in valvular echography to avoid inter operator variability.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
The direct stargegy group included patients with implanation of the THV without predilatation The reference group included patients with direct implanation of tne THV withour predilaation
Transcatheter heart valve implantation with or withour predilatatation
long term up to 5 years echographic and clinical follow up
Group 2
the echographists were blinded regarding the groups of the patients
Transcatheter heart valve implantation with or withour predilatatation
long term up to 5 years echographic and clinical follow up
Interventions
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Transcatheter heart valve implantation with or withour predilatatation
long term up to 5 years echographic and clinical follow up
Eligibility Criteria
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Inclusion Criteria
* patients included in the DIRECTAVI trial
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Florence Leclercq, PU PH
Role: STUDY_DIRECTOR
University Hospital, Montpellier
Locations
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Uhmontpellier
Montpellier, , France
Countries
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References
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Jammoul N, Dupasquier V, Akodad M, Meunier PA, Moulis L, Soltani S, Macia JC, Robert P, Schmutz L, Steinecker M, Piot C, Targosz F, Benkemoun H, Lattuca B, Roubille F, Cayla G, Leclercq F. Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial. Am Heart J. 2024 Apr;270:13-22. doi: 10.1016/j.ahj.2024.01.005. Epub 2024 Jan 20.
Other Identifiers
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RECHMPL21_0342
Identifier Type: -
Identifier Source: org_study_id
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