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.
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|