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First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair

NCT04178213 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-02-16

No results posted yet for this study

Summary

This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.

Conditions

  • Aortic Stenosis
  • Aortic Insufficiency

Interventions

DEVICE

Implantation of ADAPT 3D ALR

The operation is performed through a median sternotomy and with the hemodynamic support of standard cardiopulmonary bypass (CBP). diseased leaflets are excised meticulously. Calcifications at the level of the annulus will be removed just like in any other aortic valve replacement procedure. The annulus will be sized and the appropriate 3D single piece valve will be chosen. The implant technique will consist out of one running suture line at the level of the annulus, followed by fixation of the 3 commissural parts against the aortic wall. Valve competence and function will be assessed visually, and by TEE immediately coming of bypass.

Sponsors & Collaborators

  • Factory CRO for Medical Devices B.V.

    collaborator OTHER

  • Anteris Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Bart Meuris, Prof. Dr. · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-26
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Belgium

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 NCT04178213 on ClinicalTrials.gov