Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction

Aortic Valve Stenosis Clinical Trial

— ROTAS  

Official title:

Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03667365
• Other study ID #: 35RC17_8843_ROTAS
• Secondary ID: 2018-A02100-55
• Status: Terminated
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: November 16, 2021

Study information

• Verified date: February 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: November 16, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >18 years

2. Symptomatic and severe AS defined by an effective AVA =1 cm² and indexed AVA =0.6 cm2/m2

3. LVEF =50%

4. MAG <40 mm Hg (measure confirmed by the multi-window continuous-wave Doppler interrogation and use of Pedoff probe)

5. Confirmation of the presence of severe AS at DSE and MDCT aortic calcium score

6. Feasibility of AVR by surgery or TAVR according to the "heart team"

7. Signature of an informed consent

Exclusion Criteria:

1. Uncontrolled atrial of ventricular arrhythmias

2. Patient having a life expectancy <1 year, independently from their aortic pathology

3. Coronary artery disease necessitating a percutaneous or surgical revascularisation

4. Presence of a concomitant valve disease needing surgical treatment

5. Patient who are included in another research protocol

6. Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• aortic valve replacement
aortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization)

Other:
• strict clinical surveillance
strict clinical surveillance strategy

Locations

Country	Name	City	State
Belgium	CHU Liège	Liège
France	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
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

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	rate of all-cause mortality		2 years
Secondary	rate of cardiovascular mortality		2 years
Secondary	rate of cardiovascular related hospitalization		2 years
Secondary	rate of cerebrovascular events		2 years
Secondary	walking distance	6-minute walking test	6, 12, 18 and 24 months
Secondary	NT-proBNP plasma levels		6, 12, 18 and 24 months
Secondary	quality of life score	test EQ-5D	6, 12, 18 and 24 months