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The SOLACE-AU Clinical Trial (SOLACE-AU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01675596
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Pacific Clinical Research Group
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Severe, Symptomatic Aortic Stenosis Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis Not Applicable

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].

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test
SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Operable subjects
Other Name: Implantation of the Transcatheter Aortic Valve Prosthesis




Primary Outcome Measures :
  1. VARC-2 Composite Safety Endpoint [ Time Frame: 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 :
  1. All Cause Mortality [ Time Frame: 30 days ]
  2. All Cause Mortality [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675596


Locations
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Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Macquarie Unversity Hospital
Macquarie Park, New South Wales, Australia, 2109
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
St Vincent's Hospital - MELBOURNE
Melbourne, Victoria, Australia, 3065
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Royal Perth Hospital/Fiona Stanley Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Edwards Lifesciences
Pacific Clinical Research Group
Investigators
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Principal Investigator: Dr. Owen Christopher Raffel The Prince Charles Hospital
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01675596    
Other Study ID Numbers: 2011-14
First Posted: August 30, 2012    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
Aortic Stenosis
Transfemoral
Transcatheter Heart Valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction