Severe, Symptomatic Aortic StenosisSOLACE-AUNCT01675596

The SOLACE-AU Clinical Trial

A study testing TAVR Implantation of the Transcatheter Aortic Valve Prosthesis in people with Severe, Symptomatic Aortic Stenosis, run by Edwards Lifesciences at 11 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Severe, Symptomatic Aortic Stenosis
What is being tested?: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 11 sitesAustralia
Study dates: Apr 2012to 8 Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Australia11 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Prince Charles Hospital
Chermside, Queensland, 4032
Macquarie Unversity Hospital
Macquarie Park, New South Wales, 2109
The Alfred Hospital
Melbourne, Victoria, 3004
St Vincent's Hospital - MELBOURNE
Melbourne, Victoria, 3065
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal Perth Hospital/Fiona Stanley Hospital
Perth, Western Australia, 6000
Prince of Wales Hospital
Randwick, New South Wales, 2031
Royal North Shore Hospital
St Leonards, New South Wales, 2065

Other trials in Australia

About this study

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

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.

Read the 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].

Conditions: Severe, Symptomatic Aortic Stenosis
Being tested: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Keywords: Aortic Stenosis, Transfemoral, Transcatheter Heart Valve
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice
Also called Implantation of the Transcatheter Aortic Valve Prosthesis
Operable subjects

Study groups in NCT01675596
Study group	Role	What they receive
Test	Experimental	SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems. Receives: Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

VARC-2 Composite Safety Endpoint
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.
Measured: 30 days

Secondary outcomes (2)

All Cause Mortality
Measured: 30 days
All Cause Mortality
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20128 Aug 2018

First posted30 Aug 2012 (estimated)
Study startApr 2012
Primary completionFeb 2016
Study completion8 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Severe, Symptomatic Aortic StenosisStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01675596
Sponsor's protocol ID: 2011-14
Acronym: SOLACE-AU
Status last verified: Mar 2019
First submitted: 28 Aug 2012
Last updated: 16 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Active, not recruiting
Portico Next Generation Approval Study
Symptomatic Severe Aortic Stenosis
Not yet recruiting
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Active, not recruiting
DurAVR™ THV System: EMBARK Study
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis

All Severe, Symptomatic Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01675596
Acronym / sponsor ID: SOLACE-AU / 2011-14
Conditions: Severe, Symptomatic Aortic Stenosis
Keywords: Aortic Stenosis, Transfemoral, Transcatheter Heart Valve
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Collaborators: Pacific Clinical Research Group
Study start: Apr 2012 (actual)
Primary completion: Feb 2016 (actual)
Study completion: 8 Aug 2018 (actual)
First posted: 30 Aug 2012 (estimated)
Results: Posted 16 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Test	Experimental	Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisSAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAVR Implantation of the Transcatheter Aortic Valve ProsthesisAlso: Implantation of the Transcatheter Aortic Valve ProsthesisOperable subjects	Device	Test

Primary outcome

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.

2 secondary outcomes

All Cause Mortality
Time frame: 30 days
All Cause Mortality
Time frame: 12 months

Results and safety

Results posted to the registry on 16 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAVR With SAPIEN XT THV	199	191

Primary outcome: VARC-2 Composite Safety Endpoint

Time frame: 30 days. Number. Unit: percentage of patients

Measure	TAVR With SAPIEN XT THV n = 199
Value	12.1

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAVR With SAPIEN XT THV	73 of 199 (36.7%)	182 of 199 (91.5%)	17 of 199

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Severe, Symptomatic Aortic Stenosis

RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Active, not recruiting
Portico Next Generation Approval Study
Symptomatic Severe Aortic Stenosis
Not yet recruiting
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Active, not recruiting
DurAVR™ THV System: EMBARK Study
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Owen Christopher Raffel principal investigator

The Prince Charles Hospital

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TAVR Implantation of the Transcatheter Aortic Valve Prosthesis in people with Severe, Symptomatic Aortic Stenosis, run by Edwards Lifesciences at 11 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VARC-2 Composite Safety Endpoint (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01675596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019; AzTrials last refreshed its copy on 28 Oct 2026.