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Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
510
Start Date
2026-10-26
Completion Date
2033-12-31
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Meril Octapro+ THV System
TAVI treatment with Meril Octapro+ THV System
Abbott Navitor/Navitor Vision THV system
TAVI treatment with Abbott Navitor/Navitor Vision System
Locations (1)
University Medical Center Hamburg-Eppendorf (UKE), University Heart and Vascular Center Hamburg
Hamburg, Free and Hanseatic City of Hamburg, Germany