The SOLACE-AU Clinical Trial

Severe, Symptomatic Aortic Stenosis Clinical Trial

— SOLACE-AU  

Official title:

A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675596
• Other study ID #: 2011-14
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: August 8, 2018

Study information

• Verified date: March 2019
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: August 8, 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe, Symptomatic Aortic Stenosis

Intervention

Device:
• TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Operable subjects

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Macquarie Unversity Hospital	Macquarie Park	New South Wales
Australia	St Vincent's Hospital - MELBOURNE	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Royal Perth Hospital/Fiona Stanley Hospital	Perth	Western Australia
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Royal North Shore Hospital	St. Leonards	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Edwards Lifesciences	Pacific Clinical Research Group

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VARC-2 Composite Safety Endpoint	The primary endpoint is a VARC-2 Composite. It comprises of; All cause mortality; All stroke; Life-threatening bleeding; Acute kidney injury - Stage 3 (including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complications; Valve related dysfunction (requiring repeat procedure); A composite endpoint is an endpoint that is a combination of multiple components.	30 days
Secondary	All Cause Mortality		30 days
Secondary	All Cause Mortality		12 months