NCT04370041

Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement

Multicenter, Non-randomized Clinical Trial to Reinforce the Current Efficacy and Safety Clinical Data of the Dokimos Plus Aortic Valve

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Swan Medical S. L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stenosis
• Regurgitation, Aortic

Interventions

Type	Name	Description
DEVICE	Dokimos Plus aortic valve	Dokimos Plus aortic valve

Timeline

• Start date: 2020-09-02
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2020-04-30
• Last updated: 2022-12-20

Locations

3 sites across 1 country: Spain