Aortic Valve Stenosis
Conditions
Keywords
TAVI, TAVR, Aortic valve stenosis, Bioprostheses, Transcatheter Heart Valves, Balloon-expanding, Self-expanding, Aortic annulus, Hemodynamics
Brief 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.
Detailed description
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.
Interventions
DEVICEMeril Octapro+ THV System
TAVI treatment with Meril Octapro+ THV System
DEVICEAbbott Navitor/Navitor Vision THV system
TAVI treatment with Abbott Navitor/Navitor Vision System
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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 * Currently participating in another investigational drug or device trial * Urgent or emergency TAVI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Safety according to VARC-3 Criteria | 30 Days | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic performance (Mean aortic gradient) | 12 Months and 5 Years | \- Transvalvular mean pressure gradient ( mmHg, Continuous Variable) |
| Paravalvular leakage ≥ moderate | 12 months and 5 years | Rate of significant paravalvular leakage (≥ moderate) |
| Freedom from All-cause mortality, Disabling stroke and Rehospitalization | 5 Years | Composite Endpoint |
| Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint) | 5 Years | * 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 |
| Rate of Permanent Pacemaker Implantation | 5 Years | Implantation of a Permanent Pacemaker due to Conduction disturbances |
| Rate of Any Stroke | 5 Years | Minor, Major and Disabling Stroke |
| New York Heart Association functional class compared to baseline | 5 Years | Symptom relief (Dyspnea) |
| Left ventricular ejection fraction compared to baseline | 5 Years | Left Ventricular Function parameter |
| Length of hospital stay at discharge | 30 Days | Length of hospital stay at discharge |
| Technical success according to VARC-3 criteria | 30 Days | * 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 |
| Device success according to VARC-3 criteria | 30 Days | * 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 |
| Rate of New onset of atrial fibrillation or atrial flutter | 30 Days | New onset of atrial fibrillation or atrial flutter |
Countries
Germany
Contacts
CONTACTAndreas Schaefer, PD Dr. med.
Outcome results
None listed