Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark — CAVALIER  

Aortic Valve Replacement Clinical Trial

Official title: Perceval S Valve Clinical Trial for Extended CE Mark

Status Terminated

Clinical Trial Summary

The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Clinical Trial Description

Primary Endpoints

The primary endpoint of the clinical investigation is the evaluation of the safety and effectiveness of the Perceval S valve at 12 months after implant.

The safety of Perceval valve will be assessed in terms of percentage incidence of mortality and morbidity at 12 months after implant.

The effectiveness of the Perceval s valve will be assessed in terms of:

• Improvement of clinical status by mean of New York Heart Association (NYHA) functional class at 12 months after implant

• Haemodynamic performance through echocardiography parameters as mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation at 12 months after implant

In order to determine mortality and morbidity, the following specific device related and procedure related adverse event categories will be assessed:

• valvular thrombosis, thromboembolism, hemorrhage (whether or not related to anti coagulant/ antiplatelet drug therapy) [all and major], paravalvular leak (all and major), endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation (all and valve related), explant, death (all and valve related), device dislodgement and device migration

In order to assess the Haemodynamic performance the following echocardiography parameters will be measured:

• mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation

Secondary Endpoints

The secondary endpoints of the clinical investigation are:

• Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and at 3-6 months after implant

• Evaluation of the effectiveness of Perceval S valve in terms of improvement of clinical status assessed by means of NYHA functional class at discharge (or 30 days if the patient is still hospitalized), 3-6 months after surgery

• Evaluation of the effectiveness of Perceval S valve in terms of haemodynamic performance through echocardiography at discharge (or 30 days if the patient is still hospitalized) and 3-6 months after surgery

• Mortality and morbidity as well as haemodynamic parameters will be assessed

The Protocol has been amended (CAVALIER TPS001 Rev 4.0 Nov 17, 2017) to continue the follow up of a selection of implanted patients annually up to 10 years to evaluate long term device performance in the top enroller investigational sites.

The following secondary endpoints have been added:

• Assessment of mortality and morbidity rates annually until 10 years follow up. In order to determine mortality and morbidity, the following specific device related and procedure related adverse event categories will be assessed: valvular thrombosis, thromboembolism, hemorrhage (whether or not related to anti coagulant/ antiplatelet drug therapy) [all and major], paravalvular leak, endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation, explant, death (all and valve related), device dislodgement and device migration.

• Evaluation of the effectiveness of Perceval valve in terms of improvement of clinical status assessed by NYHA change from baseline versus each follow-up up to 10 years.

• Evaluation of the effectiveness of Perceval valve in terms of haemodynamic performance through echocardiography at each follow up until 10 years. In order to assess the haemodynamic performance the following echocardiography parameters will be measured: mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation. ;

Related Conditions & MeSH terms

• Aortic Valve Replacement

• NCT number: NCT01368666
• Study type: Interventional
• Source: Corcym S.r.l
• Status: Terminated
• Phase: N/A
• Start date: February 23, 2010
• Completion date: January 31, 2020