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.
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
Uni- or bicuspid aortic valve pathology
Severe Left ventricular outflow tract (LVOT) calcification with prohibitive risk for BE THV as determined by heart team
Non-calcified aortic valve pathology or endocarditis
Expected life expectancy <12 months due to associated non-cardiac comorbidities
Parallel
Meril Octapro+ THV System
DeviceTAVI treatment with Meril Octapro+ THV System
Abbott Navitor/Navitor Vision THV system
DeviceTAVI treatment with Abbott Navitor/Navitor Vision System
Early Safety according to VARC-3 Criteria
* Freedom from all-cause mortality * Freedom from all stroke * Freedom from VARC type 2-4 bleeding * Freedom from major vascular, access-related, or cardiac structural complication * Freedom from acute kidney injury stage 3 or 4 * Freedom from moderate or severe aortic regurgitation * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities * Freedom from surgery or intervention related to the device
Hemodynamic performance (Mean aortic gradient)
\- Transvalvular mean pressure gradient ( mmHg, Continuous Variable)
Paravalvular leakage ≥ moderate
Rate of significant paravalvular leakage (≥ moderate)
Freedom from All-cause mortality, Disabling stroke and Rehospitalization
Composite Endpoint
Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)
* Valve mean gradient of 20 mm Hg or higher * Incidence of Nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or at least moderate aortic regurgitation * Incidence of Clinical valve thrombosis; endocarditis * Incidence of Aortic-valve reintervention
Freedom from All-cause mortality, Disabling stroke and Rehospitalization
Composite endpoint
Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)
* Valve mean gradient of 20 mm Hg or higher * Incidence of Nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or at least moderate aortic regurgitation * Incidence of Clinical valve thrombosis; endocarditis * Incidence of Aortic-valve reintervention
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