NCT03667365: ROTAS

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

Terminated NA Last updated 1 March 2023

What this trial tests

NA trial testing aortic valve replacement in Aortic Valve Stenosis in 52 participants. Terminated before completion.

Timeline

19 March 2019

Primary endpoint
16 November 2021

16 November 2021

Quick facts

Lead sponsor	Rennes University Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	19 March 2019
Primary completion	16 November 2021
Estimated completion	16 November 2021
Sites	18 locations across Belgium, France

Drugs / interventions tested

• aortic valve replacement
• strict clinical surveillance

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →

Sponsor

Rennes University Hospital

Who can join

18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. TAVI in patients with low-flow low-gradient aortic stenosis-short-term and long-term outcomes.
   Steffen J, Reißig N, Andreae D, Beckmann M, et al · · 2022 · cited 23× · PMID 35320407 · DOI 10.1007/s00392-022-02011-4
2. Rationale and design of <b>SAVI-AoS:</b> A <b>physiologic</b> study of patients with symptomatic moderate aortic valve stenosis and preserved left ventricular ejection fraction.
   Eerdekens R, Tonino P, Zelis J, Adrichem R, et al · · 2022 · cited 1× · PMID 35663622 · DOI 10.1016/j.ijcha.2022.101063