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ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis

NCT02950428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-23

No results posted yet for this study

Summary

The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

ACURATE neo™TA Delivery System

ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk

Sponsors & Collaborators

  • Symetis SA

    lead INDUSTRY

Principal Investigators

  • Markus Pr Schönburg, Prof.Dr.Med · Abteilung Herzchirurgie Kerckhoff-Klinik

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-18
Primary Completion
2017-04-17
Completion
2021-09-03

Countries

  • Germany

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 NCT02950428 on ClinicalTrials.gov