StenosisNCT04370041
Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
A study testing Dokimos Plus aortic valve in people with Stenosis and Regurgitation, Aortic, run by Swan Medical S. L. at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis, Regurgitation, Aortic
- What is being tested?
- Dokimos Plus aortic valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesSpain
- Study dates
- 2 Sep 2020to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clínic Barcelona
Barcelona, 08036
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: 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.
Read the 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
- Being tested
- Dokimos Plus aortic valve
- Keywords
- Stenosis, Regurgitation, Aortic
- Medical subject headings
- Constriction, Pathologic, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dokimos Plus aortic valveDevice
Dokimos Plus aortic valve
| Study group | Role | What they receive |
|---|---|---|
| Dokimos Plus aortic valve implantation | Experimental | Dokimos Plus aortic valve implantation in all included patients. Receives: Device: Dokimos Plus aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transvalvular gradient
Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.
Measured: Up to 12 months
Secondary outcomes (4)
Number of participants with abasence of valve deterioration
Assess the absence of structural valve deterioration (morphological and hemodynamic) after 12 months follow-up.
Measured: 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.
Measured: 12 months
Number of participants with absence of endocarditis or thrombosis
Asses the absence of endocarditis or thrombosis.
Measured: 10 years
Number of participants with need for prosthetic replacement
Assess the need for prosthetic replacement.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start2 Sep 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swan Medical S. L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Muñoz, Principal investigator, Head of Cardiac Surgery Service in the Hospital GT i Pujol, Badalona, BarcelonaManuel Castellà, Principal investigator, Head of Cardiac Surgery Service in the Hospital Clínic de BarcelonaAlbert Miralles, Principal investigator, Head of Cardiac Surgery Service in HU. de Bellvitge, Hospitalet de Ll, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370041
- Sponsor's protocol ID
- DKPLUS2020
- Status last verified
- Dec 2022
- First submitted
- 27 Apr 2020
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Non-randomized Clinical Trial to Reinforce the Current Efficacy and Safety Clinical Data of the Dokimos Plus Aortic Valve
- ClinicalTrials.gov ID
- NCT04370041
- Acronym / sponsor ID
- DKPLUS2020
- Conditions
- Stenosis, Regurgitation, Aortic
- Keywords
- Stenosis, Regurgitation, Aortic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Swan Medical S. L.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dokimos Plus aortic valve implantation | Experimental | Device: Dokimos Plus aortic valveDokimos Plus aortic valve implantation in all included patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dokimos Plus aortic valveDokimos Plus aortic valve | Device | Dokimos Plus aortic valve implantation |
Primary outcome
Transvalvular gradient
Time frame: Up to 12 months
Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.
4 secondary outcomes
Number of participants with abasence of valve deterioration
Time frame: 12 months
Number of participants with absence of non-structural valve deterioration
Time frame: 12 months
Number of participants with absence of endocarditis or thrombosis
Time frame: 10 years
Number of participants with need for prosthetic replacement
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Muñoz principal investigator
Head of Cardiac Surgery Service in the Hospital GT i Pujol, Badalona, Barcelona
Manuel Castellà principal investigator
Head of Cardiac Surgery Service in the Hospital Clínic de Barcelona
Albert Miralles principal investigator
Head of Cardiac Surgery Service in HU. de Bellvitge, Hospitalet de Ll, Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dokimos Plus aortic valve in people with Stenosis and Regurgitation, Aortic, run by Swan Medical S. L. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transvalvular gradient (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.