Alliance X4 - Wesley Research Institute

The objective of this study is to demonstrate the safety and functionality of the Edwards 12F Sheath Introducer Set in conjunction with the Edwards SAPIEN X4 THV in subjects with symptomatic, severe, calcific AS.

Research Objectives

Status

Current

Recruitment

Open

Total participants required

5

Study location

Wesley Research Institute & St Andrew's War Memorial Hospital

Study type

Industry Sponsored

Patient group

People with severe aortic stenosis otherwise known as narrowing or constriction of their aortic valve may be eligible for this trial.

About this clinical trial

This study investigates the safety and efficacy of the Edwards 12F Sheath Introducer Set, a new and smaller sheath designed for transcatheter aortic valve replacement (TAVR) procedures. Researchers aim to determine whether the Edwards 12F Sheath can effectively deliver the Edwards SAPIEN X4 THV, a type of artificial aortic valve, while reducing the risk of vascular complications associated with TAVR. If successful, the Edwards 12F Sheath could offer a safer and more effective option for TAVR, improving the treatment of AS and potentially reducing the burden of this common valvular disease.

Eligibility

1. Severe, calcific Aortic Stenosis

2. Aortic size suitable for SAPIEN X4 Transcatheter Heart Valve

3. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

  Lead investigator  
          Dr Karl Poon      

  Experienced investigator  
          Dr Alexander Incani      

  Clinical trial coordinator  
          Linda Pearce      

Technical title

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

Contact for more information

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