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

Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04370041
• Other study ID #: DKPLUS2020
• Status: Terminated
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: November 4, 2022

Study information

• Verified date: December 2022
• Source: Swan Medical S. L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Regurgitation, Aortic
• Stenosis

Intervention

Device:
• Dokimos Plus aortic valve
Dokimos Plus aortic valve

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic Barcelona	Barcelona
Spain	Hospital Universitario Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Swan Medical S. L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transvalvular gradient	Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.	Up to 12 months
Secondary	Number of participants with abasence of valve deterioration	Assess the absence of structural valve deterioration (morphological and hemodynamic) after 12 months follow-up.	12 months
Secondary	Number of participants with absence of non-structural valve deterioration	Assess the absence of non-structural valve deterioration after 12 months follow-up.	12 months
Secondary	Number of participants with absence of endocarditis or thrombosis	Asses the absence of endocarditis or thrombosis.	10 years
Secondary	Number of participants with need for prosthetic replacement	Assess the need for prosthetic replacement.	10 years