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PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

NCT05539573 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1043

Last updated 2024-04-10

No results posted yet for this study

Summary

Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation).

The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.

The study will collect data from patients treated with the ACURATE neo2™ and its transfemoral delivery system following standard TAVI practice at each participating center. All patients will be followed to 12 months after the implant procedure. The study is divided into three periods: 1. Screening period: from screening to enrollment if study criteria are met. 2. Implantation procedure: immediately pre-implant to 24 hours post-procedure. 3. Follow-up period: at hospital discharge, at 30 days and at 12 months post-procedure.

Sponsors & Collaborators

  • National University of Ireland, Galway

    collaborator UNKNOWN

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Holger Thiele, Prof. Dr. · Leipzig University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • France
  • Germany
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05539573 on ClinicalTrials.gov