Aortic Valve StenosisROTASNCT03667365
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
A study testing aortic valve replacement and strict clinical surveillance in people with Aortic Valve Stenosis, run by Rennes University Hospital at 18 sites in 2 countries.
Trial summary
According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) >40 mmHg, and a maximal aortic velocity >4 m/sec. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- aortic valve replacement and strict clinical surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 19 Mar 2019to 16 Nov 2021
- 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
- Age >18 years
- Symptomatic and severe AS defined by an effective AVA ≤1 cm² and indexed AVA ≤0.6 cm2/m2
- LVEF ≥50%
- MAG <40 mm Hg (measure confirmed by the multi-window continuous-wave Doppler interrogation and use of Pedoff probe)
- Confirmation of the presence of severe AS at DSE and MDCT aortic calcium score
- Feasibility of AVR by surgery or TAVR according to the "heart team"
- Signature of an informed consent
Who cannot join
- Uncontrolled atrial of ventricular arrhythmias
- Patient having a life expectancy <1 year, independently from their aortic pathology
- Coronary artery disease necessitating a percutaneous or surgical revascularisation
- Presence of a concomitant valve disease needing surgical treatment
- Patient who are included in another research protocol
- Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
France17 sites
CHU Amiens - Picardie
Amiens
CHU Angers
Angers
CHU Brest - Hôpital La Cavale Blanche
Brest
APHP - CHU Henri Mondor
Créteil
CHU Dijon - Hôpital François Mitterrand
Dijon
CHU Lille
Lille
CH Bretagne Sud
Lorient
APHM - Hôpital La Timone
Marseille
Clinique du Millénaire
Montpellier
CHU Nantes
Nantes
CHU Rennes
Rennes, 35000
CH Saint-Brieuc
Saint-Brieuc
Centre Cardiologique du Nord
Saint-Denis
CHU Toulouse - Hôpital Rangueil
Toulouse
CHU Tours - Hôpital Trousseau
Tours
CHU Nancy
Vandœuvre-lès-Nancy
CH Bretagne Atlantique - Site de Vannes
Vannes
About this study
According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) >40 mmHg, and a maximal aortic velocity >4 m/sec.
Aortic valve replacement (AVR) is recommended (class I indication) in patients with "classical" severe AS who have any symptoms related to aortic valve disease.
Read more
In 2007, Hachicha et al. described a particular pattern of severe AS, characterized by an AVA ≤0.6 cm2/m2, low mean pressure aortic gradient (MAG <40 mmHg), despite the presence of a preserved left ventricular ejection fraction (LVEF ≥50%). This pattern of AS is encountered in nearly 15-25 % of patients who have severe AS. Typically, these patients are elderly subjects, with several comorbidities, a small left ventricular (LV) cavity with pronounced LV concentric remodeling and a restrictive physiology, leading to a decrease in LV stroke volume despite a preserved LVEF. The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because:
- the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach;
- the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established.
In very recently updated European guidelines on the management of VHD, symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR. No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS. This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up.
- Conditions
- Aortic Valve Stenosis
- Being tested
- aortic valve replacement, strict clinical surveillance
- Keywords
- severe aortic valve stenosis, low gradient, preserved left ventricular ejection fraction, symptomatic patients
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic valve replacementProcedure or surgery
aortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization)
strict clinical surveillanceOther
strict clinical surveillance strategy
| Study group | Role | What they receive |
|---|---|---|
| aortic valve replacement | Experimental | Not described Receives: Procedure: aortic valve replacement |
| strict clinical surveillance | Active comparator | Not described Receives: Other: strict clinical surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from randomization to first occurrence of any of the components of the composite outcome (adjudicated): all-cause mortality or cardiovascular related hospitalization
Measured: during 2 years follow-up
Secondary outcomes (7)
rate of all-cause mortality
Measured: 2 years
rate of cardiovascular mortality
Measured: 2 years
rate of cardiovascular related hospitalization
Measured: 2 years
rate of cerebrovascular events
Measured: 2 years
walking distance
6-minute walking test
Measured: 6, 12, 18 and 24 months
NT-proBNP plasma levels
Measured: 6, 12, 18 and 24 months
quality of life score
test EQ-5D
Measured: 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start19 Mar 2019
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Why it stopped: new US guidelines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena EG Galli, MD, Principal investigator, Rennes University HospitalErwan ED Donal, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667365
- Sponsor's protocol ID
- 35RC17_8843_ROTAS
- Other IDs
- 2018-A02100-55
- Acronym
- ROTAS
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2018
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT03667365
- Acronym / sponsor ID
- ROTAS / 35RC17_8843_ROTAS
- Conditions
- Aortic Valve Stenosis
- Keywords
- severe aortic valve stenosis, low gradient, preserved left ventricular ejection fraction, symptomatic patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new US guidelines
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 12 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.
According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) >40 mmHg, and a maximal aortic velocity >4 m/sec.
Aortic valve replacement (AVR) is recommended (class I indication) in patients with "classical" severe AS who have any symptoms related to aortic valve disease.
In 2007, Hachicha et al. described a particular pattern of severe AS, characterized by an AVA ≤0.6 cm2/m2, low mean pressure aortic gradient (MAG <40 mmHg), despite the presence of a preserved left ventricular ejection fraction (LVEF ≥50%). This pattern of AS is encountered in nearly 15-25 % of patients who have severe AS. Typically, these patients are elderly subjects, with several comorbidities, a small left ventricular (LV) cavity with pronounced LV concentric remodeling and a restrictive physiology, leading to a decrease in LV stroke volume despite a preserved LVEF. The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because:
- the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach;
- the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established.
In very recently updated European guidelines on the management of VHD, symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR. No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS. This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aortic valve replacement | Experimental | Procedure: aortic valve replacement |
| strict clinical surveillance | Active comparator | Other: strict clinical surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Symptomatic and severe AS defined by an effective AVA ≤1 cm² and indexed AVA ≤0.6 cm2/m2
- LVEF ≥50%
- MAG <40 mm Hg (measure confirmed by the multi-window continuous-wave Doppler interrogation and use of Pedoff probe)
- Confirmation of the presence of severe AS at DSE and MDCT aortic calcium score
Key exclusion criteria (6 listed)
- Uncontrolled atrial of ventricular arrhythmias
- Patient having a life expectancy <1 year, independently from their aortic pathology
- Coronary artery disease necessitating a percutaneous or surgical revascularisation
- Presence of a concomitant valve disease needing surgical treatment
- Patient who are included in another research protocol
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 |
|---|---|---|
| aortic valve replacementaortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization) | Procedure or surgery | aortic valve replacement |
| strict clinical surveillancestrict clinical surveillance strategy | Other | strict clinical surveillance |
Primary outcome
time from randomization to first occurrence of any of the components of the composite outcome (adjudicated): all-cause mortality or cardiovascular related hospitalization
Time frame: during 2 years follow-up
7 secondary outcomes
rate of all-cause mortality
Time frame: 2 years
rate of cardiovascular mortality
Time frame: 2 years
rate of cardiovascular related hospitalization
Time frame: 2 years
rate of cerebrovascular events
Time frame: 2 years
walking distance
Time frame: 6, 12, 18 and 24 months
NT-proBNP plasma levels
Time frame: 6, 12, 18 and 24 months
quality of life score
Time frame: 6, 12, 18 and 24 months
Results and safety
The study was stopped early (reason given: new US guidelines). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- 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.
Elena EG Galli, MD principal investigator
Rennes University Hospital
Erwan ED Donal, PhD principal investigator
Rennes University Hospital
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aortic valve replacement and strict clinical surveillance in people with Aortic Valve Stenosis, run by Rennes University Hospital at 18 sites in 2 countries.
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 7 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: stopped early, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Belgium. 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: new US guidelines). 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?
time from randomization to first occurrence of any of the components of the composite outcome (adjudicated): all-cause mortality or cardiovascular related hospitalization (time frame: during 2 years follow-up). 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 1 Mar 2023.