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Post-marketing surveillance registry of the CardioRoot graft.
Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardioRoot | All subjects receive the CardioRoot graft at baseline implant procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioRoot graft | Device | prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Graft complications | Complications will be assessed out to one year post implantation. | 30 days |
| Graft complications | Complications will be assessed out to one year post implantation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Subject mortality rate | Subject mortality rate will be followed out to one year post implantation. | 30 days, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with aneurysmal and occlusive disease of the thoracic aorta treated with a CARDIOROOT vascular graft.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Olomouc | Olomouc | 775 20 | Czechia | |||
| General University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31113456 | Derived | Tasca G, Lindner J, Barandon L, Santavy P, Antona C, Burkert J, Gamba A. Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study. J Cardiothorac Surg. 2019 May 21;14(1):94. doi: 10.1186/s13019-019-0914-y. |
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| Prague |
| 128 08 |
| Czechia |
| University Hospital Motol | Prague | 150 06 | Czechia |
| Centre Hospitalier Universitaire (CHU) de Bordeaux | Bordeaux | 33404 | France |
| Ospedale Manzoni di Lecco | Lecco | 23900 | Italy |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |