DurAVR™ THV System: First-In-Human Study

Status Active, not recruiting

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 25 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

Clinical Trial Details

NCT number	NCT05182307
Study type	Interventional
Source	Anteris Technologies Ltd.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 15, 2021
Completion date	January 2025

View Details

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
Completed	`NCT03314857` - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population	N/A
Active, not 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Withdrawn	`NCT03247465` - Image Fusion and Calcification Raising in Trans Aortic Valve Implantation	N/A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)
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
Completed	`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
Recruiting	`NCT04861805` - Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System	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Withdrawn	`NCT02088021` - Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access	N/A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
Active, not recruiting	`NCT05712161` - Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study	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
Active, not recruiting	`NCT04722250` - SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial	N/A