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The CoreValve Advance study is intended to evaluate the clinical utility 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| severe aortic valve stenosis | elderly patients with severe aortic valve stenosis requiring treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic CoreValve System | Device | Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac & Cerebrovascular Events (MACCE) | MACCE is defined as a composite of:
The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Device Success | Device Success is defined as a composite of:
|
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Inclusion Criteria:
Exclusion Criteria:
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patients with severe aortic valve stenosis requiring treatment, who are selected to be treated electively with the Medtronic CoreValve System
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| Name | Affiliation | Role |
|---|---|---|
| Axel Linke, Prof Dr med | Universitat Leipzig Herzzentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Antwerpen Middelheim | Antwerp | 2020 | Belgium | |||
| Antwerpen UZA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28633375 | Derived | 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. | |
| 28484830 | Derived |
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Start Recruitment March 2010 > End Recruitment July 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Medtronic CoreValve System | Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| up to 24 hours |
| Percentage of Participants With Procedural Success | Procedural success, defined as device success with absence of in-hospital MACCE | up to 30 days |
| Antwerp |
| 2650 |
| Belgium |
| CHU Sart Tillman | Liège | 4000 | Belgium |
| Angiografia de Occidente | Cali | Colombia |
| Rigshospitalet | Copenhagen | DK2100 | Denmark |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Hopital Cardiologique | Lille | 59037 | France |
| Hopital Louis Pradel | Lyon | 69677 | France |
| Institut Hospitalier Jacques Cartier | Massy | 91300 | France |
| Groupe Hospitalier Pitie-Salpetriere | Paris | 75013 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Universitätsklinikum Aachen | Aachen | 52057 | Germany |
| Bernau Herzzentrum Brandenburg | Bernau B. Berlin | 16321 | Germany |
| CardioVascular Center Frankfurt | Frankfurt | 60389 | Germany |
| Asklepios Klinik St. Georg Hamburg | Hamburg | 20099 | Germany |
| Universitat Leipzig Herzzentrum | Leipzig | 04289 | Germany |
| Deutsches Herzzentrum Munchen | München | 80636 | Germany |
| Helios Herzzentrum Siegburg Gmbh | Siegburg | 53721 | Germany |
| Onassis cardiac surgery center | Athens | 17674 | Greece |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Sheba Medical Center | Tel Aviv | 52621 | Israel |
| Ichilov Medical Center | Tel Aviv | 64239 | Israel |
| Azienda Ospedaliere Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Policlinico Vittorio Emanuele, P.O. Ferrarotto | Catania | 95024 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | 50134 | Italy |
| Ospedale Civile | Legnano | Italy |
| Ospedale Niguarda Ca'Granda | Milan | 20025 | Italy |
| Fondazione Centro San Raffaele | Milan | Italy |
| Istituto Clinico S.Ambrogio | Milan | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| AMC Ziekenhuis | Amsterdam | 1100 DD | Netherlands |
| Amphia Breda | Breda | 4818 CK | Netherlands |
| Catharina Hospital | Eindhoven | 5623 EJ | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Hospital de Santa Cruz | Lisbon | 2799-523 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia | Porto | 4400 | Portugal |
| Universtiy Hospital Isel Bern | Bern | 3010 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Brighton and Sussex Hospital | Brighton | BN25BE | United Kingdom |
| Leeds General Infirmary | Leeds | LS13EX | United Kingdom |
| Leicester Hospital | Leicester | Le3 9 QP | United Kingdom |
| St. George's Hospital | London | SW170QT | United Kingdom |
| The Heart Hospital | London | W1G8PH | United Kingdom |
| Newcross Hospital Wolverhampton | Wolverhampton | WV10 OEN | United Kingdom |
| Bleiziffer 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. |
| 26892451 | Derived | Brecker 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. |
| 26762727 | Derived | Barbanti 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. |
| 26184612 | Derived | Bosmans 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. |
| Attempted Implant |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medtronic CoreValve System | Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Cardiac & Cerebrovascular Events (MACCE) | MACCE is defined as a composite of:
The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days. | All attempted population. | Posted | Number | Freedom from MACCE (%) @30days | 30 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Device Success | Device Success is defined as a composite of:
| All attempted population in which the separate variables related to device success (see outcome measure description) were analyzable. | Posted | Number | percentage of participants | up to 24 hours |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Procedural Success | Procedural success, defined as device success with absence of in-hospital MACCE | All attempted population in which the separate variables related to procedural success (see outcome measure description) were analyzable. | Posted | Number | percentage of participants | up to 30 days |
|
|
30 days post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medtronic CoreValve System | Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System | 541 | 996 | 541 | 996 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders |
| |||
| Vessel dissection | Injury, poisoning and procedural complications |
| |||
| Access site complication | Injury, poisoning and procedural complications |
| |||
| Access vessel dissection | Injury, poisoning and procedural complications |
| |||
| Access vessel perforation | Injury, poisoning and procedural complications |
| |||
| Acute vessel occlusion | Injury, poisoning and procedural complications |
| |||
| Hemorrhage requiring transfusion | Injury, poisoning and procedural complications |
| |||
| Bradycardia | Cardiac disorders |
| |||
| Reposition with snare | Injury, poisoning and procedural complications |
| |||
| Valve in valve | Injury, poisoning and procedural complications |
| |||
| Valve retrieval | Injury, poisoning and procedural complications |
| |||
| Valve dislocation into LVOT | Injury, poisoning and procedural complications |
| |||
| Valve dislocation into annular aorta | Injury, poisoning and procedural complications |
| |||
| Ventricular rupture | Injury, poisoning and procedural complications |
| |||
| Hemodynamic instability requiring Heart/Lung machine | Vascular disorders |
| |||
| Resuscitation | Surgical and medical procedures |
| |||
| Ventricular fibrillation | Cardiac disorders |
| |||
| Failure of closure device requiring surgery | Surgical and medical procedures |
| |||
| Arrhythmia | Cardiac disorders |
| |||
| Other Procedural Complication | Injury, poisoning and procedural complications |
| |||
| Death | General disorders |
| |||
| Stroke/TIA | Nervous system disorders |
| |||
| Myocardial Infarction | Cardiac disorders | Myocardial infarction was defined according to the definition proposed by the The Joint ESC/ACC/AHA/WHF Task Force and Academic Research Consortium.(Thygesen K, Alpert JS, White HD. Circulation. 2007;116:2634-2653) |
| ||
| Renal Failure | Renal and urinary disorders |
| |||
| Structural Valve Deterioration | Cardiac disorders |
| |||
| Nonstructural Valve Dysfunction | Cardiac disorders |
| |||
| Bleeding Event | Vascular disorders | Any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (i.e. vision loss) or necessitates transfusion. |
| ||
| Permanent Pacemaker Implantation | Surgical and medical procedures |
| |||
| Other Serious Adverse Event | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE related to Device | General disorders |
| |||
| AE related to Index procedure | General disorders |
|
PI will provide results to sponsor for review and approval at least 60 days prior to submittal for publication or presentation. Review will be limited to determination whether Confidential Information is disclosed and not to censor or interfere with presentation or conclusions beyond the extent necessary to protect Confidential Information, to allow the sponsor to protect its rights in patentable or copyrightable material, and to check for technical correctness of sponsor information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanne Gonnissen | Medronic Bakken Research Center | +3143356 | 6734 | hanne.gonnissen@medtronic.com |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|