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

NCT04370041 | Terminated DMC

• 1 other identifier: DKPLUS2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Stenosis; Regurgitation, Aortic

Keywords

Stenosis; Regurgitation, Aortic

Outcome Measures

Primary Outcomes (1)

• Transvalvular gradient

  Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.

  Up to 12 months

Secondary Outcomes (4)

• Number of participants with abasence of valve deterioration

  12 months

• Number of participants with absence of non-structural valve deterioration

  12 months

• Number of participants with absence of endocarditis or thrombosis

  10 years

• Number of participants with need for prosthetic replacement

  10 years

Study Arms (1)

Dokimos Plus aortic valve implantation

EXPERIMENTAL

Dokimos Plus aortic valve implantation in all included patients.

Device: Dokimos Plus aortic valve

Interventions

Dokimos Plus aortic valve DEVICE

Dokimos Plus aortic valve

Dokimos Plus aortic valve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Swan Medical S. L.: lead

Study Sites (3)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Constriction, Pathologic; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study intends to reinforce the current clinical information regarding safety and efficacy of the Dokimos Plus aortic valve prosthesis in patients over 65 or younger with contraindication for long-term anticoagulation, in which an aortic valve replacement with a bioprosthesis has been indicated.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: September 2, 2020
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

ES (3)