ArticleAsiaIntervention2025
Initial experience with the Crea Aortic Valve System - a first-in-human study.
Article in AsiaIntervention, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Transcatheter aortic valve implantation (TAVI) is a minimally invasive option for severe aortic stenosis (AS). The Crea Aortic Valve (CAV) is a new self-expanding transcatheter aortic valve implant that has been successfully tested in preclinical studies. Aims: We aimed to assess the technical success, device performance, and early safety of the CAV System in a first-in-human study for the device in patients with severe AS. Methods: We prospectively evaluated the CAV using the Valve Academic Research Consortium (VARC)-3 criteria in three high-risk patients with severe AS. A computed tomography angiography and transthoracic echocardiographic (TTE) assessment were carried out, which was followed by TAVI according to standard protocol. TTE was performed before and after the procedure, before discharge, and at the 1- and 6-month clinical follow-ups to monitor the aortic valve area, the maximum velocity (Vmax), the mean (MG) and peak pressure gradients, and paravalvular leak (PVL). Results: The CAV was successfully implanted, using the cusp-overlap technique for patient 1 and the coplanar view for patients 2 and 3, with good usability of the delivery system for optimal positioning, reduction of the Vmax to <2 m/s and MG to <10 mmHg, and trivial PVL. An atrioventricular block necessitating a permanent pacemaker occurred in one patient. There was no incidence of stroke, heart failure, or renal failure at 6 months of follow-up. Conclusions: The CAV was implanted with success, and the system performed as intended as per VARC-3 criteria. The device should be evaluated in a larger clinical study for further efficacy and safety data.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.