DIRECTAVILONG
5 Years Hemodynamic and Clinical Follow-up of the SAPIEN 3 Transcatheter Heart Valve According to the Implantation Strategy: Insight From the Randomized DIRECTAVI Trial
Sponsor study identifier
observational
236
1 country
1
Study Start
May 1, 2021
Actual (reported)Primary Completion
August 1, 2023
Actual (reported)Study Completion
August 1, 2023
Actual (reported)A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2021
Actual (reported)November 10, 2021
Actual (reported)December 1, 2021
Actual (reported)August 1, 2023
Actual (reported)August 1, 2023
Actual (reported)the incidence of patients without THV dysfunction
the incidence of patients without THV dysfunction according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)
up to 5 years
the incidence of patients without correct hemodynamic performance
the incidence of patients without correct hemodynamic performance according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)
up to 5 years
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
the echographists were blinded regarding the groups of the patients
long term up to 5 years echographic and clinical follow up
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients included in the DIRECTAVI trial
Uhmontpellier
Montpellier, 34295, France
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.
Florence Leclercq, PU PH
University Hospital, Montpellier
236 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2021
First Posted
December 1, 2021
Study Start
May 1, 2021
Actual (reported)Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery
Contact the study team to confirm eligibility.
Primary Completion
August 1, 2023
Actual (reported)Study Completion
August 1, 2023
Actual (reported)Last Updated
January 17, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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