The SOLACE-AU Clinical Trial

Edwards Lifesciences

Status: Completed

Conditions: Severe, Symptomatic Aortic Stenosis

Treatments: Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01675596

2011-14

Details and patient eligibility

About

The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

Full description

This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial [NCT01314313].

Enrollment: 199 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 70 years
• STS Score > 4
• Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate

Exclusion criteria

• Age <70 years
• Evidence of an acute myocardial infarction ≤ 30 days
• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
• Stroke or transient ischemic attack (TIA) within 6 months of the procedure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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199 participants in 1 patient group

Test

Experimental group

Description:

SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.

Treatment:

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis