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

Not Applicable

Terminated

• Conditions: Stenosis; Regurgitation, Aortic
• Interventions: Device: Dokimos Plus aortic valve

• Registration Number: NCT04370041
• Lead Sponsor: Swan Medical S. L.

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 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.

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Study Start: 2020-09-02
• Primary Completion: 2022-11-04
• Study Completion: 2022-11-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients over 18
2. 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).
3. Patient candidates to an aortic bioprosthesis implantation according to the standard clinical practice guidelines.
4. Patients requiring isolated aortic valve replacement, or in combination with coronary artery bypass surgery and / or in combination with ascending aorta replacement surgery.
5. 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 Criteria

1. Cardiac surgery contraindications.
2. 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.
3. Patients with LVEF < 30%.
4. Cardiac surgery reintervention.
5. Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery.
6. Patient who are not willing to attend to the required follow-up visit.
7. 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).
8. Patient undergoing hemodialysis or with severe renal impairment (eGFR<30ml/min/1,7m2).
9. Pregnant women.
10. Patients with hyperparathyroidism.
11. Life expectancy less than 2 years.
12. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dokimos Plus aortic valve implantation	Dokimos Plus aortic valve	Dokimos Plus aortic valve implantation in all included patients.

Primary Outcome Measures

Name	Time	Method
Transvalvular gradient	Up to 12 months	Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.

Secondary Outcome Measures

Name	Time	Method
Number of participants with absence of non-structural valve deterioration	12 months	Assess the absence of non-structural valve deterioration after 12 months follow-up.
Number of participants with need for prosthetic replacement	10 years	Assess the need for prosthetic replacement.
Number of participants with abasence of valve deterioration	12 months	Assess the absence of structural valve deterioration (morphological and hemodynamic) after 12 months follow-up.
Number of participants with absence of endocarditis or thrombosis	10 years	Asses the absence of endocarditis or thrombosis.

Trial Locations

Locations (3)

Hospital Clínic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain