Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
NCT04370041 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2022-12-20
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.
Conditions
- Stenosis
- Regurgitation, Aortic
Interventions
- DEVICE
-
Dokimos Plus aortic valve
Dokimos Plus aortic valve
Sponsors & Collaborators
-
Swan Medical S. L.
lead INDUSTRY
Principal Investigators
-
Christian Muñoz · Head of Cardiac Surgery Service in the Hospital GT i Pujol, Badalona, Barcelona
-
Manuel Castellà · Head of Cardiac Surgery Service in the Hospital Clínic de Barcelona
-
Albert Miralles · Head of Cardiac Surgery Service in HU. de Bellvitge, Hospitalet de Ll, Barcelona
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-02
- Primary Completion
- 2022-11-04
- Completion
- 2022-11-04
Countries
- Spain
Study Locations
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