Aortic StenosisNCT01676727
ADVANCE Direct Aortic Study
An observational study of Aortic Stenosis and Valvular Heart Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 6 countries.
Trial summary
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aortic Stenosis, Valvular Heart Disease
- What is being tested?
- CoreValve aortic valve
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Sep 2012to Aug 2015
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe aortic stenosis who are scheduled for an elective transcatheter aortic valve implantation and who are selected (e.g. because of an calcified femoral artery) to receive the CoreValve® device via direct aortic access.
Who may be able to join
- Severe symptomatic aortic valve stenosis requiring treatment
- Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
- 21 years of age or older
- Patient is willing and able to comply with all protocol-specified follow-up evaluations
- The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
- Patient will receive the CoreValve® device via direct aortic approach TAVI -
Who cannot join
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
- Sepsis, including active endocarditis
- Recent myocardial infarction (<30 days)
- Left ventricular or atrial thrombus by echocardiography
- Uncontrolled atrial fibrillation
- Mitral or tricuspid valvular insufficiency (>grade II)
Show all 20Show fewer
- Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
- Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Patients with:
- Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
- Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or
- Thoracic aortic aneurysm in the path of delivery system
- Bleeding diathesis or coagulopathy
- Patient refuses blood transfusion
- Estimated life expectancy of less than 12 months unless TAVI is performed
- Creatine clearance <20 mL/min
- Active gastritis or peptic ulcer disease
- Pregnancy or intent to become pregnant during study follow up
- Patient is participating in another trial that may influence the results of this study
- -
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Italy2 sites
Azienda spedaliera Spedali Civili Di Brescia
Brescia, 25123
Azienda spedaliera Niguarda Ca' Granda Milano
Milan, 20162
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Medisch centrum Leeuwarden
Leeuwarden
United Kingdom2 sites
Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital
Brighton
Royal Brompton & Harefield NHS Trust
London, SW3 6NP
About this study
Official title: CoreValve® ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.
Read the detailed description
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.
- Conditions
- Aortic Stenosis, Valvular Heart Disease
- Being tested
- CoreValve aortic valve
- Keywords
- Transcatheter Aortic valve Implantation, Heart Valve Diseases, Cardiovascular Diseases
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreValve aortic valveDevice
Implantation of CoreValve aortic valve via direct aortic approach
| Study group | Role | What they receive |
|---|---|---|
| CoreValve aortic valve | Implantation of CoreValve aortic valve via direct aortic approach Receives: Device: CoreValve aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality
Kaplan-Meier estimate of 30-day all-cause mortality.
Measured: 30 days post-implant
Secondary outcomes (1)
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
The combined safety endpoint is defined as a composite 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 complication
- Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
- High degree AV block requiring permanent pacemaker implantation
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionAug 2015
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 Aortic StenosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Moat, M.D., Principal investigator, The Royal Brompton HospitalGiuseppe Bruschi, M.D., Principal investigator, Azienda spedaliera Niguarda Ca' Granda Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676727
- Sponsor's protocol ID
- Advance-DA
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2012
- Last updated
- 19 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoreValve® ADVANCE Direct Aortic Study
- ClinicalTrials.gov ID
- NCT01676727
- Acronym / sponsor ID
- Advance-DA
- Conditions
- Aortic Stenosis, Valvular Heart Disease
- Keywords
- Transcatheter Aortic valve Implantation, Heart Valve Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.
Detailed description
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoreValve aortic valve | – | Device: CoreValve aortic valveImplantation of CoreValve aortic valve via direct aortic approach |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe aortic stenosis who are scheduled for an elective transcatheter aortic valve implantation and who are selected (e.g. because of an calcified femoral artery) to receive the CoreValve® device via direct aortic access.
Key inclusion criteria (6 listed)
- Severe symptomatic aortic valve stenosis requiring treatment
- Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
- 21 years of age or older
- Patient is willing and able to comply with all protocol-specified follow-up evaluations
- The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
Key exclusion criteria (20 listed)
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
- Sepsis, including active endocarditis
- Recent myocardial infarction (<30 days)
- Left ventricular or atrial thrombus by echocardiography
- Uncontrolled atrial fibrillation
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 |
|---|---|---|
| CoreValve aortic valveImplantation of CoreValve aortic valve via direct aortic approach | Device | CoreValve aortic valve |
Primary outcome
All-cause Mortality
Time frame: 30 days post-implant
Kaplan-Meier estimate of 30-day all-cause mortality.
1 secondary outcome
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 1, 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Neil Moat, M.D. principal investigator
The Royal Brompton Hospital
Giuseppe Bruschi, M.D. principal investigator
Azienda spedaliera Niguarda Ca' Granda Milano
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Valvular Heart Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 6 countries.
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 6 inclusion and 20 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Netherlands, United Kingdom, Czechia, France and 1 more country. 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 30 Jul 2018). 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?
All-cause Mortality (time frame: 30 days post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2018.