Status:
TERMINATED
Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
Lead Sponsor:
Swan Medical S. L.
Conditions:
Stenosis
Regurgitation, Aortic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 biopro...
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 st...
Eligibility Criteria
Inclusion
- Patients over 18
- Patients with the ability to understand the study requirements, be able to given written informed consent, and be willing and able to comply with the study requirements (including follow-up visits).
- Patient candidates to an aortic bioprosthesis implantation according to the standard clinical practice guidelines.
- Patients requiring isolated aortic valve replacement, or in combination with coronary artery bypass surgery and / or in combination with ascending aorta replacement surgery.
- Women are eligible for the study if: a) are not pregnant or breastfeeding, b) are not of childbearing potential, c) if women of childbearing potential, a negative urine pregnancy test should be done within 48 hours before the intervention and must use an effective contraceptive method.
Exclusion
- Cardiac surgery contraindications.
- Patients who require other interventions than the isolated aortic valve replacement or with coronary artery bypass surgery and / or in combination with ascending aorta replacement surgery as concomitant procedure.
- Patients with LVEF \< 30%.
- Cardiac surgery reintervention.
- Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery.
- Patient who are not willing to attend to the required follow-up visit.
- Patients with active endocarditis (in the case of cured endocarditis, the presence of at least two negative blood cultures must be confirmed before their inclusion in the study).
- Patient undergoing hemodialysis or with severe renal impairment (eGFR\<30ml/min/1,7m2).
- Pregnant women.
- Patients with hyperparathyroidism.
- Life expectancy less than 2 years.
- Patients with a history or diagnosis of a medical problem or psychiatric illness or disorder that, according to the investigator evaluation, would make the patient not eligible to participate in the study.
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04370041
Start Date
September 2 2020
End Date
November 4 2022
Last Update
December 20 2022
Active Locations (3)
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1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Clínic Barcelona
Barcelona, Spain, 08036