This study intends to reinforce the current clinical information regarding safety and efficacy of the Dokimos Plus aortic valve prosthesis in patients in whom an aortic valve replacement with a bioprosthesis has been indicated.
Multicenter, non-randomized, longitudinal case series clinical trial designed to reinforce the current safety and efficacy clinical data of the Dokimos Plus aortic valve and renew the CE mark. The study foresees the inclusion of 80 patients recruited prospectively. Patients over 65 who have been diagnosed with a heart valve disease and who require surgical aortic valve replacement, or younger patients who are unsuitable for long-term anticoagulation due to medical contraindications or lifestyle considerations. The study will collect information on the Dokimos Plus aortic valve transvalvular gradient at 6 months and 12 months after the implantation. In addition, patients will be annually followed-up, up to 10 years after implantation. The objective of the study valve is to improve life expectancy and quality of life of patients with a diseased aortic valve, replacing it with a bioprosthesis that can be safely implanted, with good hemodynamics and long durability. Clinical studies carried out up to date have shown that the Dokimos Plus aortic valve presents satisfactory clinical and hemodynamic results, similar to those of other bioprothesis available on the market. In addition, the post-marketing surveillance carried out by the manufacturer has not revealed any relevant events regarding the Dokimos Plus aortic valve safety profile.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Dokimos Plus aortic valve
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clínic Barcelona
Barcelona, Spain
Transvalvular gradient
Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.
Time frame: Up to 12 months
Number of participants with abasence of valve deterioration
Assess the absence of structural valve deterioration (morphological and hemodynamic) after 12 months follow-up.
Time frame: 12 months
Number of participants with absence of non-structural valve deterioration
Assess the absence of non-structural valve deterioration after 12 months follow-up.
Time frame: 12 months
Number of participants with absence of endocarditis or thrombosis
Asses the absence of endocarditis or thrombosis.
Time frame: 10 years
Number of participants with need for prosthetic replacement
Assess the need for prosthetic replacement.
Time frame: 10 years
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