CardioRoot Post-Marketing Surveillance Registry (CardioRoot)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01609270|
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment|
|Cardiovascular Surgical Procedure||Device: CardioRoot graft|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Official Title:||CardioRoot Post-Marketing Surveillance Registry|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2017|
All subjects receive the CardioRoot graft at baseline implant procedure.
Device: CardioRoot graft
prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position.
- Graft complications [ Time Frame: 30 days ]Complications will be assessed out to one year post implantation.
- Graft complications [ Time Frame: 1 year ]Complications will be assessed out to one year post implantation.
- Subject mortality rate [ Time Frame: 30 days, 1 year ]Subject mortality rate will be followed out to one year post implantation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609270
|University Hospital Olomouc|
|Olomouc, Czechia, 775 20|
|General University Hospital|
|Prague, Czechia, 128 08|
|University Hospital Motol|
|Prague, Czechia, 150 06|
|Centre Hospitalier Universitaire (CHU) de Bordeaux|
|Bordeaux, France, 33404|
|Ospedale Manzoni di Lecco|
|Lecco, Italy, 23900|
|Ospedale Luigi Sacco|
|Milano, Italy, 20157|