The SOLACE-AU Clinical Trial

Not Applicable

Completed

• Conditions: Severe, Symptomatic Aortic Stenosis
• Interventions: Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

• Registration Number: NCT01675596
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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.

Detailed 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 \[NCT01314313\].

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Primary Completion: 2016-02
• Study Completion: 2018-08-08
• Results First Submitted: 2019-02-15
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test	TAVR Implantation of the Transcatheter Aortic Valve Prosthesis	SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.

Primary Outcome Measures

Name	Time	Method
VARC-2 Composite Safety Endpoint	30 days	The primary endpoint is a VARC-2 Composite. It comprises of; 1. All cause mortality; 2. All stroke; 3. Life-threatening bleeding; 4. Acute kidney injury - Stage 3 (including renal replacement therapy); 5. Coronary artery obstruction requiring intervention; 6. Major vascular complications; 7. Valve related dysfunction (requiring repeat procedure); A composite endpoint is an endpoint that is a combination of multiple components.

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality	12 months

Trial Locations

Locations (11)

Macquarie Unversity Hospital; 🇦🇺 Macquarie Park, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

The Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Royal Perth Hospital/Fiona Stanley Hospital; 🇦🇺 Perth, Western Australia, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

St Vincent's Hospital - MELBOURNE; 🇦🇺 Melbourne, Victoria, Australia