Clinical Trials Logo

Clinical Trial Summary

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

Clinical Trial Description

The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve. The study will enroll up to 10 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05182307
Study type Interventional
Source Admedus Regen Pty Ltd.
Status Active, not recruiting
Phase N/A
Start date November 15, 2021
Completion date June 2023

See also
  Status Clinical Trial Phase
Completed NCT03003650 - ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort N/A
Active, not recruiting NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Recruiting NCT04091048 - Optimize PRO Study
Withdrawn NCT03247465 - Image Fusion and Calcification Raising in Trans Aortic Valve Implantation N/A
Completed NCT03143686 - ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
Recruiting NCT04861805 - A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System N/A
Active, not recruiting NCT03466918 - China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population N/A
Completed NCT01819181 - Women's INternational Transcatheter Aortic Valve Implantation Registry
Recruiting NCT04331145 - Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation Phase 4
Recruiting NCT02803294 - Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population Phase 4
Completed NCT02536196 - The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation N/A
Withdrawn NCT02088021 - Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access N/A
Terminated NCT02759237 - The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS) N/A
Recruiting NCT01794832 - Severe Aortic Stenosis in Patients Referred for Valve Surgery N/A
Completed NCT02424370 - Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation
Completed NCT01493284 - Portico TAVI Implant With Transfemoral Delivery System N/A
Completed NCT02664649 - Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis Phase 3
Completed NCT01487330 - First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System N/A
Recruiting NCT04722250 - SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial N/A