Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
Key facts
- Where
- Hamburg, GermanySee the site
Where in Germany
- University Medical Center Hamburg-Eppendorf (UKE), University Heart and Vascular Center HamburgHamburg, GermanyContact: Andreas Schaefer, PD Dr. med.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Universitätsklinikum Hamburg-Eppendorf
- Trial code
- NCT07794306
- Record updated
- 31 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.