Key result
New RCT protocol tests if direct TAVI without predilatation is noninferior to standard TAVI.
Why the study?
Balloon predilatation during TAVI has been considered essential, but recent evidence suggests it may cause complications and might be unnecessary with new-generation valves.
Does direct transcatheter aortic valve implantation without prior balloon dilatation improve immediate procedural success compared to TAVI with prior balloon valvuloplasty in patients with an indication for TAVI?
RCT (n=240)
Open-label
1:1 ratio and permuted blocks of 4 and 6
No
Does direct transcatheter aortic valve implantation without prior balloon dilatation improve immediate procedural success compared to TAVI with prior balloon valvuloplasty in patients with an indication for TAVI?
This study protocol outlines a randomized controlled trial to determine if direct TAVI without prior balloon predilatation is noninferior to the standard approach with predilatation.
Answers are grounded in this paper and cite their sources.
RCT protocol tests noninferiority of direct TAVI; leaves open whether predilatation can be omitted.
BACKGROUND: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. METHODS/DESIGN: The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure. DISCUSSION: This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.
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Leclercq et al. (2017) conducted an RCT in Severe symptomatic aortic stenosis (n=240). Direct transcatheter aortic valve implantation (without prior balloon dilatation) vs. Transcatheter aortic valve implantation with prior balloon aortic valvuloplasty was evaluated on Immediate procedural success (absence of immediate procedural mortality, correct positioning, intended performance, and no moderate/severe regurgitation). This study protocol describes a randomized controlled trial designed to evaluate whether direct transcatheter aortic valve implantation without prior balloon dilatation is noninferior to the standard approach with predilatation.
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