Tissue DopplerAURIFERNCT05150366
Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler (AURIFER)
A study testing Trans thoracic echocardiography in people with Tissue Doppler and Left Atrial Closure, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tissue Doppler, Left Atrial Closure
- What is being tested?
- Trans thoracic echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2021to 25 Feb 2025
- 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
- Man or woman over 18 years-old
- Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants
- Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
- Patient in sinus rhythm
- Subject affiliated or beneficiary of a social security scheme
- Patient having signed the informed consent
Who cannot join
- Patient participating in another clinical study
- Patient in permanent ACFA
- Patient with a mitral prosthesis (biological or mechanical),
- Patient with a history of mitral annuloplasty
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
- Pregnant, breastfeeding or parturient woman;
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler
The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.
- Conditions
- Tissue Doppler, Left Atrial Closure
- Being tested
- Trans thoracic echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans thoracic echocardiographyProcedure or surgery
trans thoracic echocardiography at the beggining and at the end of the placement of the Saint Jude Medical AMULET type prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device | Experimental | Not described Receives: Procedure: Trans thoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
lateral e' speed
measured by tissue Doppler
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start17 Sep 2021
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue DopplerStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150366
- Sponsor's protocol ID
- 2020-A02663-36
- Acronym
- AURIFER
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler
- ClinicalTrials.gov ID
- NCT05150366
- Acronym / sponsor ID
- AURIFER / 2020-A02663-36
- Conditions
- Tissue Doppler, Left Atrial Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 9 Dec 2021 (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 main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device | Experimental | Procedure: Trans thoracic echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman over 18 years-old
- Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants
- Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
- Patient in sinus rhythm
- Subject affiliated or beneficiary of a social security scheme
Key exclusion criteria (7 listed)
- Patient participating in another clinical study
- Patient in permanent ACFA
- Patient with a mitral prosthesis (biological or mechanical),
- Patient with a history of mitral annuloplasty
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
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 |
|---|---|---|
| Trans thoracic echocardiographytrans thoracic echocardiography at the beggining and at the end of the placement of the Saint Jude Medical AMULET type prosthesis | Procedure or surgery | Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device |
Primary outcome
lateral e' speed
Time frame: 1 day
measured by tissue Doppler
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 16 Jul 2026.
Related trials for Tissue Doppler
RecruitingObservational study
The Use of Single-Beat TE-e' in Evaluation of Left Atrial Pressure in Critically Ill Patients: The TELAP-ICU Trial
Critical Illness, Elevated Left Atrial Pressure
Not yet recruitingObservational study
Ultrasound and Shear Wave Elastography Assessment of Entheses in Psoriatic Arthritis
Psoriatic Arthritis, Enthesitis
Not yet recruitingObservational study
Musculoskeletal Ultrasound in Patients With Hematologic Malignancies
Hematologic Neoplasms, Leukemia
Recruiting
Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients
Giant Cell Arteritis (GCA), Doppler Ultrasound
Not yet recruitingObservational study
Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction , and the Changes in Aortic Isthmus Doppler Parameters With Every Changes of Other Early Iugr Parameters Like EFW, Uterine Artery Doppler, Cerebroplacental Ratio and Ductus Venosus Doppler in Comparison With Normal Group .
Fetal Growth Restriction, Placental Insufficiency
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?
A study testing Trans thoracic echocardiography in people with Tissue Doppler and Left Atrial Closure, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 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 16 Jul 2026. 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?
lateral e' speed (time frame: 1 day). 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 16 Jul 2026.