Study Stopped
new US guidelines
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
ROTAS
2 other identifiers
interventional
52
2 countries
18
Brief 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. 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:
- 1.the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach;
- 2.the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2021
CompletedMarch 1, 2023
February 1, 2023
2.7 years
September 10, 2018
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time from randomization to first occurrence of any of the components of the composite outcome (adjudicated): all-cause mortality or cardiovascular related hospitalization
during 2 years follow-up
Secondary Outcomes (7)
rate of all-cause mortality
2 years
rate of cardiovascular mortality
2 years
rate of cardiovascular related hospitalization
2 years
rate of cerebrovascular events
2 years
walking distance
6, 12, 18 and 24 months
- +2 more secondary outcomes
Study Arms (2)
aortic valve replacement
EXPERIMENTALstrict clinical surveillance
ACTIVE COMPARATORInterventions
aortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CHU Liège
Liège, Belgium
CHU Amiens - Picardie
Amiens, France
CHU Angers
Angers, France
CHU Brest - Hôpital La Cavale Blanche
Brest, France
APHP - CHU Henri Mondor
Créteil, France
CHU Dijon - Hôpital François Mitterrand
Dijon, France
CHU Lille
Lille, France
CH Bretagne Sud
Lorient, France
APHM - Hôpital La Timone
Marseille, France
Clinique du Millénaire
Montpellier, France
CHU Nantes
Nantes, France
CHU Rennes
Rennes, 35000, France
CH Saint-Brieuc
Saint-Brieuc, France
Centre Cardiologique du Nord
Saint-Denis, France
CHU Toulouse - Hôpital Rangueil
Toulouse, France
CHU Tours - Hôpital Trousseau
Tours, France
CHU Nancy
Vandœuvre-lès-Nancy, France
CH Bretagne Atlantique - Site de Vannes
Vannes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena EG Galli, MD
CHU Rennes
- PRINCIPAL INVESTIGATOR
Erwan ED Donal, PhD
CHU Rennes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
March 19, 2019
Primary Completion
November 16, 2021
Study Completion
November 16, 2021
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share