Study Design
BIOPRO
HEART
The BIOPRO Trial is a retrospective, non-randomized, multicenter study designed
to perform an update on the safety and effectiveness evaluations of the BVP
(Braile Biomédica®). This study complies with the Declaration of
Helsinki and was performed according to the local ethics committee’s approval
(CIP identification #191031), following the International Organization for
Standardization [ISO] 14155:2011Patients who have received heart valves implanted at these institutions tend to
remain under follow-up at specialized ambulatory. Data were obtained from
patients’ records and examinations performed during the first year after valve
surgery, including baseline clinical data, procedure information, mortality,
AEs, and New York Heart Association (NYHA) class.Multiple patient records were tracked on electronic Case Report Forms (e-CRFs)
provided by Braile Biomédica®. A professional from Core Lab (Le
Bihan Cardiologia e Anestesia S/S Ltda) validated the echocardiographic data
about the device’s hemodynamic performance.