Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair
Recruitment status was Recruiting
Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a minimally invasive (transatrial, transapical or transfemoral) procedure. The aim of this study is to evaluate the performance and safety of the Cardioband for transatrial repair of mitral regurgitation.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair|
- safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE) until hospital discharge and at post-operative 30 days.
- Technical success rate of the implantation of the Cardioband [ Time Frame: Immedietly after implantation ] [ Designated as safety issue: No ]
- Technical feasibility of Cardioband adjustment [ Time Frame: Immedietly after procedure ] [ Designated as safety issue: No ]
- Reduce MR [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Cardioband ability to reduce mitral valve regurgitation (MR) post-procedure, at post-operative hospital discharge, and at post-operative 30 days.
- safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE)will be compared to the literature.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Device: Cardioband adjustable band
The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are reserved to fit patients with low or moderate surgical risk, and thus several patients are refused surgery because of unfavorable risk-benefit balance.Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a minimally invasive (transatrial, transapical or transfemoral) procedure. Cardioband is intended to remodel the annulus by deployment and fixation along (and direct) the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533883
|Contact: Francesco Maisano, MDfirstname.lastname@example.org|
|Hospital san raffaele||Recruiting|
|Milano, Italy, 20132|
|Contact: Ottavio Alfieri, MD|
|Contact: Francesco Maisano, MD|
|Principal Investigator: Michael Borger, MD, PhD|
|Principal Investigator:||Ottavio Alfieri, MD||Hospital San Raffaele, Milan, Italy|
|Principal Investigator:||Michael Borger, MD PhD||Heart Center Leipzig, Leipzig, Germany|