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. Product Names: * Meril Octapro+ THV System, (Commercially available in Germany) * Abbott Navitor/ Navitor Vision THV System (Commercially available in Europe/US.) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
510
TAVI treatment with Meril Octapro+ THV System
TAVI treatment with Abbott Navitor/Navitor Vision System
University Medical Center Hamburg-Eppendorf (UKE), University Heart and Vascular Center Hamburg
Hamburg, Free and Hanseatic City of Hamburg, Germany
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
Time frame: 30 Days
Hemodynamic performance (Mean aortic gradient)
\- Transvalvular mean pressure gradient ( mmHg, Continuous Variable)
Time frame: 12 Months and 5 Years
Paravalvular leakage ≥ moderate
Rate of significant paravalvular leakage (≥ moderate)
Time frame: 12 months and 5 years
Freedom from All-cause mortality, Disabling stroke and Rehospitalization
Composite Endpoint
Time frame: 5 Years
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
Time frame: 5 Years
Rate of Permanent Pacemaker Implantation
Implantation of a Permanent Pacemaker due to Conduction disturbances
Time frame: 5 Years
Rate of Any Stroke
Minor, Major and Disabling Stroke
Time frame: 5 Years
New York Heart Association functional class compared to baseline
Symptom relief (Dyspnea)
Time frame: 5 Years
Left ventricular ejection fraction compared to baseline
Left Ventricular Function parameter
Time frame: 5 Years
Length of hospital stay at discharge
Length of hospital stay at discharge
Time frame: 30 Days
Technical success according to VARC-3 criteria
* Freedom from mortality * Successful access, delivery of device and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Time frame: 30 Days
Device success according to VARC-3 criteria
* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication * Intended performance of the valve (mean gradient \< 20 mm Hg, peak velocity \< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation
Time frame: 30 Days
Rate of New onset of atrial fibrillation or atrial flutter
New onset of atrial fibrillation or atrial flutter
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.