Aortic Valve StenosisAdvance-IINCT01624870
CoreValve Advance-II Study: Prospective International Post-market Study
An observational study of Aortic Valve Stenosis and Valvular Heart Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 6 countries.
Trial summary
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Valvular Heart Disease
- How many people
- 200 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Oct 2011to Mar 2014
- 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 aortic stenosis and at elevated surgical risk are eligible to be included in the study.
Who may be able to join
- Fulfilling the criteria of labeling indications of the CoreValve System;
- Patient is above the minimum age as required by local regulations to be participating in a clinical trial regardless of gender and race;
- Provided Signed Informed Consent or Data Release Form.
Who cannot join
- Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator);
- Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines;
- Persistent or permanent atrial fibrillation (except paroxysmal AF);
- Participation in another drug or device study that would jeopardize the appropriate analysis of endpoints of this study.
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Pregnancy
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Germany3 sites
Charite, Campus Mitte - Kardiologie Berlin
Berlin, 10117
Universitätsklinikum Bonn
Bonn, 53127
Universitätsklinikum Heidelberg
Heidelberg, 69120
Italy2 sites
Istituto Clinico S. Ambrogio
Milan, 20149
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100
About this study
Official title: CoreValve Advance-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
Read the detailed description
The purpose of the study was to investigate the rate of conduction disturbances after trans-catheter aortic valve implantation of the Medtronic CoreValve device, aiming to characterize best practices. The investigators did not assign study specific interventions to the subjects in the study.
- Conditions
- Aortic Valve Stenosis, Valvular Heart Disease
- Keywords
- Aortic Valve Stenosis, Valvular Heart Disease, Transcatheter Aortic Valve Implantation
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CoreValve aortic valve | Implantation of CoreValve aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
New-onset Class I or II Indication for Permanent Pacemaker Implantation
The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or >6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.
Measured: 30 days post procedure
Secondary outcomes (1)
Combined Safety Endpoint
The Kaplan-Meier estimate of all-cause mortality, major stroke, life threatening (or disabling) bleeding, acute Kidney Injury - Stage 3 (including renal denervation therapy), peri-procedural myocardial infarction or repeat procedure for valve related dysfunction (surgical or interventional). A Kaplan Meier assessment was used to determine the composite rate.
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionMar 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Sonia Petronio, M.D., Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624870
- Sponsor's protocol ID
- Advance-II
- Acronym
- Advance-II
- Status last verified
- Aug 2018
- First submitted
- 19 Jun 2012
- Last updated
- 19 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Petronio AS, Sinning JM, Van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, Bosmans J, Bedogni F, Branny M, Stangl K, Kovac J, Schiltgen M, Kraus S, de Jaegere P. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study. JACC Cardiovasc Interv. 2015 May;8(6):837-846. doi: 10.1016/j.jcin.2015.02.005.
PubMed 25999108
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-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.
- ClinicalTrials.gov ID
- NCT01624870
- Acronym / sponsor ID
- Advance-II / Advance-II
- Conditions
- Aortic Valve Stenosis, Valvular Heart Disease
- Keywords
- Aortic Valve Stenosis, Valvular Heart Disease, Transcatheter Aortic Valve Implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Jun 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.
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
Detailed description
The purpose of the study was to investigate the rate of conduction disturbances after trans-catheter aortic valve implantation of the Medtronic CoreValve device, aiming to characterize best practices. The investigators did not assign study specific interventions to the subjects in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoreValve aortic valve | – | –Implantation of CoreValve aortic valve |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic stenosis and at elevated surgical risk are eligible to be included in the study.
Key inclusion criteria (3 listed)
- Fulfilling the criteria of labeling indications of the CoreValve System;
- Patient is above the minimum age as required by local regulations to be participating in a clinical trial regardless of gender and race;
- Provided Signed Informed Consent or Data Release Form.
Key exclusion criteria (6 listed)
- Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator);
- Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines;
- Persistent or permanent atrial fibrillation (except paroxysmal AF);
- Participation in another drug or device study that would jeopardize the appropriate analysis of endpoints of this study.
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
New-onset Class I or II Indication for Permanent Pacemaker Implantation
Time frame: 30 days post procedure
The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or >6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.
1 secondary outcome
Combined Safety Endpoint
Time frame: 30 days post procedure
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.
- Derived from this study: PubMed 25999108Petronio AS, Sinning JM, Van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, Bosmans J, Bedogni F, Branny M, Stangl K, Kovac J, Schiltgen M, Kraus S, de Jaegere P. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study. JACC Cardiovasc Interv. 2015 May;8(6):837-846. doi: 10.1016/j.jcin.2015.02.005.
- 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.
Anna Sonia Petronio, M.D. principal investigator
Azienda Ospedaliero, Universitaria Pisana
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 Valve 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 3 inclusion and 6 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 Germany, Italy, Belgium, Czechia, Netherlands 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?
New-onset Class I or II Indication for Permanent Pacemaker Implantation (time frame: 30 days post procedure). 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 NCT01624870, which also lists 1 linked publication.
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.