Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Early Safety according to VARC-3 Criteria
研究概览
简要总结
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.
详细描述
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.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intra-annular Balloon-expanding THV
干预措施: Meril Octapro+ THV System (Device)
Intra-annular Self-expanding THV
干预措施: Abbott Navitor/Navitor Vision THV system (Device)
结局指标
主要结局
Early Safety according to VARC-3 Criteria
时间窗: 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
次要结局
- Hemodynamic performance (Mean aortic gradient)(12 Months and 5 Years)
- Paravalvular leakage ≥ moderate(12 months and 5 years)
- Freedom from All-cause mortality, Disabling stroke and Rehospitalization(5 Years)
- Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)(5 Years)
- Rate of Permanent Pacemaker Implantation(5 Years)
- Rate of Any Stroke(5 Years)
- New York Heart Association functional class compared to baseline(5 Years)
- Left ventricular ejection fraction compared to baseline(5 Years)
- Length of hospital stay at discharge(30 Days)
- Technical success according to VARC-3 criteria(30 Days)
- Device success according to VARC-3 criteria(30 Days)
- Rate of New onset of atrial fibrillation or atrial flutter(30 Days)
研究者
Andreas Schäfer
PD. Dr. med. Andreas Schäfer, MHBA
Universitätsklinikum Hamburg-Eppendorf