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Completed

NCT Number: NCT01675596

The SOLACE-AU Clinical Trial

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.

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Key information

Conditions

Severe, Symptomatic Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Device

Operable subjects

Other names: Implantation of the Transcatheter Aortic Valve Prosthesis

Primary outcomes

  1. VARC-2 Composite Safety Endpoint

    Time frame: 30 days

    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.

Secondary outcomes

  1. All Cause Mortality

    Time frame: 30 days

  2. All Cause Mortality

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

  • Pacific Clinical Research Group

Registry information

Official study 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

Acronym: SOLACE-AU

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Aug 30, 2012
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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