5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI Trial

NCT05140317 | Completed

• 1 other identifier: RECHMPL21_0342
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Syndrome; Hemodynamic Instability

Keywords

patients included in the directavi trial; TAVR Hemodynamic performances long term follow up

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Procedure: Transcatheter heart valve implantation with or withour predilatatation

Group 2

the echographists were blinded regarding the groups of the patients

Procedure: Transcatheter heart valve implantation with or withour predilatatation

Interventions

Transcatheter heart valve implantation with or withour predilatatation PROCEDURE

long term up to 5 years echographic and clinical follow up

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients included in the DIRECTAVI trial

You may qualify if:

• Older than 18 years old.
• patients included in the DIRECTAVI trial

You may not qualify if:

• \- Patients not living in France

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 38253304 DERIVED

MeSH Terms

Conditions

Angina, Unstable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Florence Leclercq, PU PH

  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: November 10, 2021
• First Posted: December 1, 2021
• Study Start: May 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

FR (1)