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

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

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.

Study Overview

• Status: Terminated
• Conditions: Stenosis; Regurgitation, Aortic
• Intervention / Treatment: Device: Dokimos Plus aortic valve

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic Barcelona
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dokimos Plus aortic valve implantation; Dokimos Plus aortic valve implantation in all included patients.	Device: Dokimos Plus aortic valve; Dokimos Plus aortic valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transvalvular gradient	Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of participants with absence of endocarditis or thrombosis	Asses the absence of endocarditis or thrombosis.	10 years
Number of participants with need for prosthetic replacement	Assess the need for prosthetic replacement.	10 years

Collaborators and Investigators

• Sponsor: Swan Medical S. L.
• Investigators: Principal Investigator: Christian Muñoz, Head of Cardiac Surgery Service in the Hospital GT i Pujol, Badalona, Barcelona; Principal Investigator: Manuel Castellà, Head of Cardiac Surgery Service in the Hospital Clínic de Barcelona; Principal Investigator: Albert Miralles, Head of Cardiac Surgery Service in HU. de Bellvitge, Hospitalet de Ll, Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): November 4, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Stenosis; Regurgitation, Aortic
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: DKPLUS2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No