Valvular Heart DiseaseNATURE-VALVENCT04509479
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
An observational study of Valvular Heart Disease and Valvular Stenosis, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease, Valvular Stenosis, Valvular Insufficiency
- What is being tested?
- Valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 3,637 participants
- Where
- 1 siteTunisia
- Study dates
- 6 Jul 2020to 30 Jul 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Patients with valvular disease
Who may be able to join
- Patients originated from Tunisia
- Signed informed consent
- Patients with at least one of the following conditions :
- moderate to severe native mitral and / or aortic and / or tricuspid native valve disease
- and / or a history of a previous percutaneous or surgical valve intervention
- and / or a history of infectious endocarditis
Who cannot join
- Congenital valve diseases not including bicuspid aortic valve
- Isolated pulmonary valvulopathies
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
The Tunisian Society of Cardiology and CardioVascular Surgery
Tunis, 1053
About this study
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.
- Being tested
- Valve replacement
- Keywords
- Valvular, Heart, Aortic, Mitral, Tricuspid
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valve replacementProcedure or surgery
Description of valve replacements
What is being measured
The primary outcome is the main question the study is designed to answer.
Valvulopathies incidence
Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study
Measured: at inclusion
Secondary outcomes (1)
Major adverse cardiovascular events (MACE)
Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.
Measured: at 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start6 Jul 2020
- Primary completion31 Mar 2021
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,637 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Responsible party
- Sponsor
- Investigators
- Fathia Mghaieth, MD, Study chair, Tunisian Society of Cardiology and Cardiovascular SurgeryLilia Zakhama, MD, Study chair, Tunisian Society of Cardiology and Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509479
- Sponsor's protocol ID
- DAC-008-STCCCV
- Acronym
- NATURE-VALVE
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tunisian Registry of Valvulopathies (NATURE-VALVE)
- ClinicalTrials.gov ID
- NCT04509479
- Acronym / sponsor ID
- NATURE-VALVE / DAC-008-STCCCV
- Keywords
- Valvular, Heart, Aortic, Mitral, Tricuspid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,637 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 12 Aug 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.
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with valvular disease
Key inclusion criteria (6 listed)
- Patients originated from Tunisia
- Signed informed consent
- Patients with at least one of the following conditions :
Key exclusion criteria (2 listed)
- Congenital valve diseases not including bicuspid aortic valve
- Isolated pulmonary valvulopathies
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 |
|---|---|---|
| Valve replacementDescription of valve replacements | Procedure or surgery | – |
Primary outcome
Valvulopathies incidence
Time frame: at inclusion
Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study
1 secondary outcome
Major adverse cardiovascular events (MACE)
Time frame: at 6 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Fathia Mghaieth, MD study chair
Tunisian Society of Cardiology and Cardiovascular Surgery
Lilia Zakhama, MD study chair
Tunisian Society of Cardiology and Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease and Valvular Stenosis, run by Dacima Consulting at 1 site in Tunisia.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Valvulopathies incidence (time frame: at inclusion). 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 22 Aug 2022.