Related Experiment Video
Updated: Jun 13, 2026
Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
Evaluation of a multi-component intervention aimed at reducing time to treatment in transcatheter aortic valve
Karine Chevreul1, Morgane Michel1, Amira J Hariz1
1ECEVE, UMR 1123, Inserm, Université Paris Cité, 75010 Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Robert-Debré, Service de santé publique, équipe REPERES, 75019, 75010 Paris, France.
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.
Trial Status:
Overall, 828 patients have been enrolled. Data had not been analysed at the time the protocol was submitted.
