Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
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Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Universitätsklinikum Hamburg-Eppendorf
- Azonosító
- NCT07794306
- A regiszteradat frissítve
- 2026. augusztus 31.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: Participants 18 years of age or older; Heart team consensus that isolated transfemoral TAVI is medically justified and advisable; Diagnosis of severe symptomatic aortic valve stenosis and aortic annulus ≤ 430 mm² as seen in preoperative CT diagnostic; Anatomy is suitable for both BE and SE THVs according to Heart Team judgement; Participant provided written informed consent to participate in the trial; Ability of participant to understand patient information and to personally sign and date informed consent to participate in trial, before performing any trial-related procedures; Participant and treating physician agree that participant will return for all required postprocedural follow-up visits.
Kizáró feltételek: Currently participating in another investigational drug or device trial; Severe Left ventricular outflow tract (LVOT) calcification with prohibitive risk for BE THV as determined by heart team; Expected life expectancy <12 months due to associated non-cardiac comorbidities; Uni- or bicuspid aortic valve pathology; Non-calcified aortic valve pathology or endocarditis; Urgent or emergency TAVI.