Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve ReplacementAOMYOCNCT03686527
Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement
An observational study of Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement, run by Rennes University Hospital at 1 site in France.
Trial summary
Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement
- What is being tested?
- stenosis aortic valve
- Type of treatment
- Surgery or procedure
- How many people
- 277 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2018to 11 Jan 2019
- 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 tight aortic stenosis with an indication of surgical treatment.
Who may be able to join
- major patient freely accepting to participate in the study
- non-opposition signed
- aortic surface <1cm² or <0.6cm² / m² of indication surgical restraint
- oriented to short interventional management surgical term
- LVEF Left ventricular ejection fraction> 50%
- In the subgroup "MRI-fibrosis", absence of indication for performing MRI
Who cannot join
- patient under guardianship, curatorship or safeguard of justice
- minor patient
- pregnant woman
- patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement
- patient with severe coronary artery disease requiring revascularization
- allergy to the contrast product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve
Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.
- Being tested
- stenosis aortic valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stenosis aortic valveProcedure or surgery
The exams to be realized :
- a clinical examination with blood pressure
- a 12-lead surface electrocardiogram
- a standard biological assessment including NTproBNP (Brain Natriuretic Peptide)
- Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations)
- a cardiac MRI looking for fibrosis myocardial
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography | Not described Receives: Procedure: stenosis aortic valve | |
| MRI Fibrosis | Not described Receives: Procedure: stenosis aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement.
Measured: 1 day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start11 Jan 2018
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve ReplacementStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686527
- Sponsor's protocol ID
- 35RC12_8974 AOMYOC
- Acronym
- AOMYOC
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve
- ClinicalTrials.gov ID
- NCT03686527
- Acronym / sponsor ID
- AOMYOC / 35RC12_8974 AOMYOC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 27 Sep 2018 (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.
Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echocardiography | – | Procedure: stenosis aortic valve |
| MRI Fibrosis | – | Procedure: stenosis aortic valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tight aortic stenosis with an indication of surgical treatment.
Key inclusion criteria (6 listed)
- major patient freely accepting to participate in the study
- non-opposition signed
- aortic surface <1cm² or <0.6cm² / m² of indication surgical restraint
- oriented to short interventional management surgical term
- LVEF Left ventricular ejection fraction> 50%
Key exclusion criteria (6 listed)
- patient under guardianship, curatorship or safeguard of justice
- minor patient
- pregnant woman
- patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement
- patient with severe coronary artery disease requiring revascularization
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 |
|---|---|---|
| stenosis aortic valveThe exams to be realized : * a clinical examination with blood pressure * a 12-lead surface electrocardiogram * a standard biological assessment including NTproBNP (Brain Natriuretic Peptide) * Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations) * a cardiac MRI looking for fibrosis myocardial | Procedure or surgery | Echocardiography, MRI Fibrosis |
Primary outcome
The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement.
Time frame: 1 day of inclusion
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 26 Mar 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement, run by Rennes University Hospital at 1 site in France.
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 6 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 26 Mar 2019. 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 France. 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?
The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement. (time frame: 1 day of 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 26 Mar 2019.