Severe Aortic StenosisNCT01074658
CoreValve Advance International Post Market Study
An observational study of Severe Aortic Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 44 sites in 12 countries.
Trial summary
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- Medtronic CoreValve System
- Type of treatment
- Medical device
- How many people
- 1,015 participants
- Where
- 44 sitesin 12 countries
- Study dates
- Mar 2010to May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with severe aortic valve stenosis requiring treatment, who are selected to be treated electively with the Medtronic CoreValve System
Who may be able to join
- Patients with severe aortic valve stenosis requiring treatment
- Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context
- Patient is above the minimum age as required by local regulations to be participating in a clinical study
- 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")
Who cannot join
- Currently participating in another trial
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Pregnancy
Trial locations and contacts
44 sites in 12 countries.
44 sites in 12 countries
Italy8 sites
Azienda Ospedaliere Spedali Civili di Brescia
Brescia, 25123
Policlinico Vittorio Emanuele, P.O. Ferrarotto
Catania, 95024
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
Ospedale Civile
Legnano
Ospedale Niguarda Ca'Granda
Milan, 20025
Fondazione Centro San Raffaele
Milan
Istituto Clinico S.Ambrogio
Milan
Istituto Clinico Humanitas
Rozzano, 20089
Germany7 sites
Universitätsklinikum Aachen
Aachen, 52057
Bernau Herzzentrum Brandenburg
Bernau B. Berlin, 16321
CardioVascular Center Frankfurt
Frankfurt, 60389
Asklepios Klinik St. Georg Hamburg
Hamburg, 20099
Universitat Leipzig Herzzentrum
Leipzig, 04289
Deutsches Herzzentrum Munchen
München, 80636
Helios Herzzentrum Siegburg Gmbh
Siegburg, 53721
France6 sites
Hopital Henri Mondor
Créteil, 94010
Hopital Cardiologique
Lille, 59037
Hopital Louis Pradel
Lyon, 69677
Institut Hospitalier Jacques Cartier
Massy, 91300
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
Clinique Pasteur
Toulouse, 31076
United Kingdom6 sites
Brighton and Sussex Hospital
Brighton, BN25BE
Leeds General Infirmary
Leeds, LS13EX
Leicester Hospital
Leicester, Le3 9 QP
St. George's Hospital
London, SW170QT
The Heart Hospital
London, W1G8PH
Newcross Hospital Wolverhampton
Wolverhampton, WV10 OEN
Netherlands4 sites
AMC Ziekenhuis
Amsterdam, 1100 DD
Amphia Breda
Breda, 4818 CK
Catharina Hospital
Eindhoven, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Belgium3 sites
ZNA Antwerpen Middelheim
Antwerp, 2020
Antwerpen UZA
Antwerp, 2650
CHU Sart Tillman
Liège, 4000
Israel3 sites
Hadassah Medical Center
Jerusalem, 91120
Sheba Medical Center
Tel Aviv, 52621
Ichilov Medical Center
Tel Aviv, 64239
Portugal2 sites
Hospital de Santa Cruz
Lisbon, 2799-523
Centro Hospitalar de Vila Nova de Gaia
Porto, 4400
Switzerland2 sites
Universtiy Hospital Isel Bern
Bern, 3010
Universitätsspital Zürich
Zurich, 8091
About this study
Official title: CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
Read the detailed description
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.
- Conditions
- Severe Aortic Stenosis
- Being tested
- Medtronic CoreValve System
- Keywords
- Advance, Medtronic CoreValve System, International, Interventional, Post Market Study
- 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.
Medtronic CoreValve SystemDevice
Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System
| Study group | Role | What they receive |
|---|---|---|
| severe aortic valve stenosis | elderly patients with severe aortic valve stenosis requiring treatment Receives: Device: Medtronic CoreValve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac & Cerebrovascular Events (MACCE)
MACCE is defined as a composite of:
- All cause mortality
- Myocardial Infarction (Q-wave and non-Q-wave)
- Emergent cardiac surgery or percutaneous re-intervention
- Stroke
The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.
Measured: 30 days
Secondary outcomes (2)
Percentage of Participants With Device Success
Device Success is defined as a composite of:
- Successful device delivery;
- Stable device placement;
- Intact retrieval of delivery catheter;
- Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation
Measured: up to 24 hours
Percentage of Participants With Procedural Success
Procedural success, defined as device success with absence of in-hospital MACCE
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionMay 2017
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe 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
- 1,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Linke, Prof Dr med, Principal investigator, Universitat Leipzig Herzzentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074658
- Sponsor's protocol ID
- Advance
- Status last verified
- Oct 2017
- First submitted
- 23 Feb 2010
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gerckens U, Tamburino C, Bleiziffer S, Bosmans J, Wenaweser P, Brecker S, Guo J, Linke A. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J. 2017 Sep 21;38(36):2729-2738. doi: 10.1093/eurheartj/ehx295.
PubMed 28633375Bleiziffer S, Bosmans J, Brecker S, Gerckens U, Wenaweser P, Tamburino C, Linke A; ADVANCE Study Investigators. Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study. Clin Res Cardiol. 2017 Oct;106(10):784-795. doi: 10.1007/s00392-017-1120-3. Epub 2017 May 8.
PubMed 28484830Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.
PubMed 26892451Barbanti M, Schiltgen M, Verdoliva S, Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Gulino S, Tamburino C, Linke A; ADVANCE Study Investigators. Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study). Am J Cardiol. 2016 Mar 1;117(5):820-7. doi: 10.1016/j.amjcard.2015.11.066. Epub 2015 Dec 13.
PubMed 26762727Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Tamburino C, Linke A; ADVANCE Study Investigators. The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients. J Am Coll Cardiol. 2015 Jul 21;66(3):209-217. doi: 10.1016/j.jacc.2015.05.025.
PubMed 26184612
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.
- ClinicalTrials.gov ID
- NCT01074658
- Acronym / sponsor ID
- Advance
- Conditions
- Severe Aortic Stenosis
- Keywords
- Advance, Medtronic CoreValve System, International, Interventional, Post Market Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Posted 21 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
Detailed description
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe aortic valve stenosis | – | Device: Medtronic CoreValve Systemelderly patients with severe aortic valve stenosis requiring treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe aortic valve stenosis requiring treatment, who are selected to be treated electively with the Medtronic CoreValve System
Key inclusion criteria (4 listed)
- Patients with severe aortic valve stenosis requiring treatment
- Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context
- Patient is above the minimum age as required by local regulations to be participating in a clinical study
- 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 (3 listed)
- Currently participating in another trial
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Pregnancy
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 |
|---|---|---|
| Medtronic CoreValve SystemTranscatheter Aortic Valve Implantation of the Medtronic CoreValve System | Device | severe aortic valve stenosis |
Primary outcome
Major Adverse Cardiac & Cerebrovascular Events (MACCE)
Time frame: 30 days
MACCE is defined as a composite of: * All cause mortality * Myocardial Infarction (Q-wave and non-Q-wave) * Emergent cardiac surgery or percutaneous re-intervention * Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.
2 secondary outcomes
Percentage of Participants With Device Success
Time frame: up to 24 hours
Percentage of Participants With Procedural Success
Time frame: up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28633375Gerckens U, Tamburino C, Bleiziffer S, Bosmans J, Wenaweser P, Brecker S, Guo J, Linke A. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J. 2017 Sep 21;38(36):2729-2738. doi: 10.1093/eurheartj/ehx295.
- Derived from this study: PubMed 28484830Bleiziffer S, Bosmans J, Brecker S, Gerckens U, Wenaweser P, Tamburino C, Linke A; ADVANCE Study Investigators. Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study. Clin Res Cardiol. 2017 Oct;106(10):784-795. doi: 10.1007/s00392-017-1120-3. Epub 2017 May 8.
- Derived from this study: PubMed 26892451Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.
- Derived from this study: PubMed 26762727Barbanti M, Schiltgen M, Verdoliva S, Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Gulino S, Tamburino C, Linke A; ADVANCE Study Investigators. Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study). Am J Cardiol. 2016 Mar 1;117(5):820-7. doi: 10.1016/j.amjcard.2015.11.066. Epub 2015 Dec 13.
- Derived from this study: PubMed 26184612Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Tamburino C, Linke A; ADVANCE Study Investigators. The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients. J Am Coll Cardiol. 2015 Jul 21;66(3):209-217. doi: 10.1016/j.jacc.2015.05.025.
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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.
Axel Linke, Prof Dr med principal investigator
Universitat Leipzig Herzzentrum
44 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 44 sites in 12 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 4 inclusion and 3 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Italy, Germany, France, United Kingdom, Netherlands and 7 more countries. 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 21 Oct 2016). 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?
Major Adverse Cardiac & Cerebrovascular Events (MACCE) (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 NCT01074658, which also lists 5 linked publications.
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 2 Dec 2017.