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Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | VAVGJ |
| |
| Group 2 | CAVGJ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAVGJ | Device | Replacement of the aortic valve and ascending aorta |
| |
| Measure | Description | Time Frame |
|---|---|---|
| annualized event rate of all-cause mortality | Primary Safety Endpoint | 5 Years |
| annualized event rate of reintervention | Primary Effectiveness Endpoint | 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve and ascending aorta.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Amato | Contact | +39 335 61 40 573 | paolo.amato@abbott.com | |
| Karine Miquel | Contact | +32 479 60 01 07 | karine.miquel@abbott.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Withdrawn | Birmingham | Alabama | 35294 | United States | |
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| CAVGJ |
| Device |
Replacement of the aortic valve and ascending aorta |
|
| University of Michigan |
| Recruiting |
| Ann Arbor |
| Michigan |
| 48104 |
| United States |
| Mission Health & Hospitals | Withdrawn | Asheville | North Carolina | 28801 | United States |
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Klinik Floridsdorf | Recruiting | Vienna | 1012 | Austria |
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| CHU de Besancon - Jean Minjoz | Recruiting | Besançon | 25030 | France |
| CHRU Lille | Recruiting | Lille | 59037 | France |
| Groupe Hospitalier Bichat - Claude Bernard | Recruiting | Paris | 75877 | France |
| Herz-und Diabetes Zentrum NRW | Recruiting | Bad Oeynhausen | 32545 | Germany |
| Deutsches Herzzentrum Berlin | Recruiting | Berlin | 13353 | Germany |
| Klinikum Links der Weser | Recruiting | Bremen | 28277 | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
| Onassis Cardiac Surgery Center | Recruiting | Athens | 17674 | Greece |
| Policlinico S.Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| Policlinico San Donato | Recruiting | San Donato Milanese | 20097 | Italy |
| Wojewodzki Szpital Zespolony w Kielcach | Withdrawn | Kielce | 25-736 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II | Recruiting | Krakow | 31-202 | Poland |
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Active, not recruiting | Lodz | 92-213 | Poland |
| The Cardinal Stefan Wyszynski Institute of Cardiology | Recruiting | Warsaw | 04-628 | Poland |
| Hospital Universitario del Vinalopó | Recruiting | Elche | 03293 | Spain |
| Hospital Universitario Son Espases | Recruiting | Palma de Mallorca | 07120 | Spain |
| James Cook University Hospital | Recruiting | Middlesbrough | TS43BW | United Kingdom |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
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