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ACURATE Prime XL Human Feasibility Study

NCT05224245 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-06-15

No results posted yet for this study

Summary

To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects with severe native aortic stenosis who are indicated for TAVI.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

ACURATE Prime XL Transfemoral Aortic Valve System

ACURATE Prime™ Transfemoral Aortic Valve system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Robert Gooley, MBBS · Monash Medical Centre

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2022-06-16
Completion
2023-05-24

Countries

  • Australia

Study Locations

More Related Trials

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 NCT05224245 on ClinicalTrials.gov