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

Brief Title

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

Official Title

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

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.

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 Type

Interventional

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

Secondary Outcome

 rate of all-cause mortality

Condition

Aortic Valve Stenosis

Intervention

aortic valve replacement

Study Arms / Comparison Groups

 aortic valve replacement

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

March 19, 2019

Completion Date

March 2025

Primary Completion Date

March 19, 2024

Eligibility Criteria

        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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elena EG Galli, MD, 02 99 28 25 55, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT03667365

Organization ID

35RC17_8843_ROTAS

Secondary IDs

2018-A02100-55

Responsible Party

Sponsor

Study Sponsor

Rennes University Hospital

Study Sponsor

Elena EG Galli, MD, Principal Investigator, CHU Rennes

Verification Date

November 2019