First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Insufficiency
- Aortic Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: prospective, non-randomised, single arm, single-centre First In Human clinical investigationMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
The purpose of this study is to conduct the initial clinical investigation of single piece ADAPT treated 3D - ALR (Aortic Leaflet Repair) to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical performance with significa...
The purpose of this study is to conduct the initial clinical investigation of single piece ADAPT treated 3D - ALR (Aortic Leaflet Repair) to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical performance with significant improvements in clinical hemodynamic performance. The ADAPT® technology is used to process animal derived tissues to produce implantable tissue prosthetic devices that are compatible with the human body. This technology has been shown to produce reliable, biocompatible and versatile regenerative prosthetic devices capable of being used instead of synthetic products currently used in many soft tissue repair applications. 15 patients with aortic valve insufficiency or stenosis will be enrolled in this single arm single site study. Follow-up will continue through to 26 weeks.
Tracking Information
- NCT #
- NCT04178213
- Collaborators
- Factory CRO for Medical Devices B.V.
- Investigators
- Principal Investigator: Bart Meuris, Prof. Dr. Universitaire Ziekenhuizen Leuven
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