Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when valve deterioration occures. Especially small aortic annuli represent a special challenge in terms of postprocedural hemodynamics, however intra-annular transcatheter heart valve designs should be the devices of choice to facilitate future TAVI-in-TAVI procedures. Which intra-annular valve design offers ideal clinical and hemodynamic efficacy is unclear. Therefore, an investigator-initiated, randomized controlled trial (BALANCE trial: Balloon- vs. Self-expanding intraannular TAVI in small aortic annuli) was created to elucidate this topic.
This is a prospective, multi-center, national, randomized controlled, post-market trial.
The primary objectives of the trial are to demonstrate clinical and hemodynamic non-inferiority of the Octapro+ System when compared to subjects treated with the Navitor System at 30 days and12 months post-procedure.
Subjects will be randomized on a 2:1 basis to receive TAVI with either a Meril Balloon-expanding (BE) intraannular Transcatheter Heart Valve (THV) or an Abbott Self-expanding (SE) intraannular THV. Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.
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Currently, there is no comparative evidence for clinical and hemodynamic efficacy of the two available intra-annular THV principles (BE vs. SE) for treatment of AS in patients with small aortic annuli.
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Exclusion Criteria:
and.schaefer@uke.de+4915222816250