Evaluation of a multi-component intervention aimed at reducing time to treatment in transcatheter aortic valve implantation: Protocol for a cluster randomized controlled trial - 12/06/26

Doi : 10.1016/j.acvd.2026.05.003

Karine Chevreul ^a,^b, Morgane Michel ^a,^b, Amira J. Hariz ^a,^b,⁎ , Delphine Béziau-Gasnier ^c,^d,^e, Bernard Iung ^f,^g, Eric Durand ^c,^d,^e, Romain Didier ^h,ⁱ, Martine Gilard ^h,ⁱ, Hélène Eltchaninoff ^c,^d,^e

^a ECEVE, UMR 1123, Inserm, Université Paris Cité, 75010 Paris, France

^b Assistance Publique-Hôpitaux de Paris, Hôpital Robert-Debré, Service de santé publique, équipe REPERES, 75019, 75010 Paris, France

^c INSERM U1096, Université de Rouen Normandie, 76000 Rouen, France

^d CHU Rouen, Department of Cardiology, 76000 Rouen, France

^e Institut Alain Cribier, 76000 Rouen, France

^f INSERM LVTS 1148, Université Paris-Cité 75018, 75010 Paris, France

^g Cardiology Department, Bichat Hospital, AP–HP, 75018, 75010 Paris, France

^h INSERM UMR1304-GETBO, University of Brest, 29200 Brest, France

ⁱ Cardiology Department, CHU Brest, 292003 Brest, France

^⁎ Corresponding author. Inserm - UMR 1123, ECEVE, 10, avenue de Verdun, 75010 Paris, France. Inserm - UMR 1123, ECEVE 10, avenue de Verdun Paris 75010 France

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Friday 12 June 2026

Graphical abstract

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Highlights

•	The TREAT study evaluated a two-component intervention to reduce time to TAVI.
•	Component 1 was to improve patient and health professional knowledge.
•	Component 2 was to optimize TAVI centre organization.
•	TAVI centres were randomized to 1, 2, 1 + 2, or neither. Data analysis is ongoing.
•	Positive results could lead to improved patient outcomes and healthcare efficiency.

Le texte complet de cet article est disponible en PDF.

Abstract

Background

Transcatheter aortic valve implantation (TAVI) has become widely used to treat symptomatic patients with aortic stenosis (AS), but increasing demand has led to treatment delays, which are associated with increased morbi-mortality.

Aims

To reduce time to treatment in patients awaiting a TAVI, we constructed a multi-component intervention which includes (1) a paper- and internet-based component aimed at improving AS and TAVI knowledge and (2) an organizational component aimed at TAVI centres to improve scheduling of examinations and procedures. Their effectiveness, cost-effectiveness and implementation were evaluated in a cluster randomized controlled trial (cRCT).

Methods

The cRCT (NCT_05237804) used a factorial design to evaluate the two components of the intervention, alone and together. The cluster was the TAVI centre. As patients may be referred to TAVI centres by regional hospitals, participating regional hospitals were included in the cluster of their referral TAVI centre. Clusters were allocated to one of four treatment groups after stratification on annual number of TAVI procedures, presence of a coordinating nurse and participation of a regional hospital. Patients aged ≥ 18 years with symptomatic AS and a TAVI indication were included in the study. The expected sample size was 798 patients. The primary outcome is the percentage of patients treated within 2 months of the TAVI indication. Secondary outcomes are time to treatment, mortality, quality of life, knowledge regarding TAVI and AS, medication compliance and incremental cost-effectiveness ratios. Implementation measures include dose, fidelity, adaptations, reached population, satisfaction and acceptability.