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

Primary Purpose

Stenosis, Regurgitation, Aortic

Status

Terminated

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Dokimos Plus aortic valve

About this trial

This is an interventional treatment trial for Stenosis focused on measuring Stenosis, Regurgitation, Aortic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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).
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.

Sites / Locations

Hospital Germans Trias i Pujol
Hospital Universitario Bellvitge
Hospital Clínic Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dokimos Plus aortic valve implantation

Arm Description

Dokimos Plus aortic valve implantation in all included patients.

Outcomes

Primary Outcome Measures

Transvalvular gradient

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

Secondary Outcome Measures

Number of participants with abasence of valve deterioration

Assess the absence of structural valve deterioration (morphological and hemodynamic) after 12 months follow-up.

Number of participants with absence of non-structural valve deterioration

Assess the absence of non-structural valve deterioration after 12 months follow-up.

Number of participants with absence of endocarditis or thrombosis

Asses the absence of endocarditis or thrombosis.

Number of participants with need for prosthetic replacement

Assess the need for prosthetic replacement.

Full Information

NCT ID

NCT04370041

First Posted

April 27, 2020

Last Updated

December 15, 2022

Sponsor

Swan Medical S. L.

1. Study Identification

Unique Protocol Identification Number

NCT04370041

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision

Study Start Date

September 2, 2020 (Actual)

Primary Completion Date

November 4, 2022 (Actual)

Study Completion Date

November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swan Medical S. L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stenosis, Regurgitation, Aortic

Keywords

Stenosis, Regurgitation, Aortic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dokimos Plus aortic valve implantation

Arm Type

Experimental

Arm Description

Dokimos Plus aortic valve implantation in all included patients.

Intervention Type

Device

Intervention Name(s)

Dokimos Plus aortic valve

Intervention Description

Dokimos Plus aortic valve

Primary Outcome Measure Information:

Title

Transvalvular gradient

Description

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

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Number of participants with abasence of valve deterioration

Description

Assess the absence of structural valve deterioration (morphological and hemodynamic) after 12 months follow-up.

Time Frame

12 months

Title

Number of participants with absence of non-structural valve deterioration

Description

Assess the absence of non-structural valve deterioration after 12 months follow-up.

Time Frame

12 months

Title

Number of participants with absence of endocarditis or thrombosis

Description

Asses the absence of endocarditis or thrombosis.

Time Frame

10 years

Title

Number of participants with need for prosthetic replacement

Description

Assess the need for prosthetic replacement.

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Muñoz

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Manuel Castellà

Organizational Affiliation

Head of Cardiac Surgery Service in the Hospital Clínic de Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Albert Miralles

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Universitario Bellvitge

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Clínic Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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