PERCEVAL S REAL LIFE REGISTRY
Research type
Research Study
Full title
International multicentre real life registry with the Perceval S Heart Valve: a safety and performance evaluation.
IRAS ID
138998
Contact name
Andrew Chukwuemeka
Contact email
Sponsor organisation
Sorin Group Italia S.r.l
Research summary
Aortic valve replacement (AVR) is more and more accessible to wider patient population, offering excellent results in terms of survival and clinical outcomes. The possibilities for AVR vary a lot in terms of techniques (open heart surgery, mini-invasive surgery) and medical devices (mechanical valves, biological stented valves, biological stentless valves, transcatheter aortic valve replacement, sutureless valves). The performance of heart valve prostheses can be evaluated with the help of different parameters: (i) the evaluation of echocardiographic parameters is representing how much the prosthesis is bringing the heart situation close to a healthy one, evaluating therefore transvalvular pressure gradients, the effective orifice area represented by the valve, the reduction in the ventricular mass, linked to the recovery of the heart status; (ii) the evaluation of clinical parameters is describing the interaction of the prosthesis with the patient, and can be represented by the mortality rate together with the analysis of morbidity, which is articulated into the occurrence of several events, such as thromboembolic events, bleeding, structural valve deterioration, endocarditis, alteration of the sinus rhythm.
The current study is an observational registry aimed to record the performance of the sutureless Perceval S Heart Valve used in the standard clinical practice, without the biases introduced by (i) the selection of patients in terms of demographic characteristics, comorbidities; (ii) the selection of centres in terms of surgical team, experience with the products, standard of care, diagnostic procedures.REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1925
Date of REC Opinion
28 Feb 2014
REC opinion
Further Information Favourable Opinion