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

NCT ID: NCT03667365

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2021-11-16

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aortic valve replacement

Group Type: EXPERIMENTAL

aortic valve replacement

Intervention Type: PROCEDURE

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

strict clinical surveillance

Group Type: ACTIVE_COMPARATOR

strict clinical surveillance

Intervention Type: OTHER

strict clinical surveillance strategy

Interventions

aortic valve replacement

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

Intervention Type: PROCEDURE

strict clinical surveillance

strict clinical surveillance strategy

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena EG Galli, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Erwan ED Donal, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

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, , 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

Countries

Belgium; France

Other Identifiers

2018-A02100-55

Identifier Type: OTHER

Identifier Source: secondary_id

35RC17_8843_ROTAS

Identifier Type: -

Identifier Source: org_study_id