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

NCT ID: NCT04370041

Last Updated: 2022-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2022-11-04

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.

Conditions

Stenosis; Regurgitation, Aortic

Keywords

Stenosis; Regurgitation, Aortic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dokimos Plus aortic valve implantation

Dokimos Plus aortic valve implantation in all included patients.

Group Type: EXPERIMENTAL

Dokimos Plus aortic valve

Intervention Type: DEVICE

Dokimos Plus aortic valve

Interventions

Dokimos Plus aortic valve

Dokimos Plus aortic valve

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swan Medical S. L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Muñoz

Role: PRINCIPAL_INVESTIGATOR

Head of Cardiac Surgery Service in the Hospital GT i Pujol, Badalona, Barcelona

Manuel Castellà

Role: PRINCIPAL_INVESTIGATOR

Head of Cardiac Surgery Service in the Hospital Clínic de Barcelona

Albert Miralles

Role: PRINCIPAL_INVESTIGATOR

Head of Cardiac Surgery Service in HU. de Bellvitge, Hospitalet de Ll, Barcelona

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Clínic Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

DKPLUS2020

Identifier Type: -

Identifier Source: org_study_id