ACURATE Enhance Post Market Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 主要终点
- Primary Endpoint:
研究概览
简要总结
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
详细描述
ACURATE Enhance is a prospective, open-label, single-arm, multicenter, post-market study in patients implanted with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) for the treatment of severe calcific aortic stenosis in a routine clinical setting.
A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the ACURATE neo2 Delivery System. Up to 150 subjects will be enrolled.
Follow-up will occur at pre-discharge, 30 days, 6 months and 1 year post index procedure per standard of care. Visits are in-person at 30 days and 1 year. The 6 month visits is in-person (preferred) or via telephone interview.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has documented severe aortic stenosis and an aortic annulus size compatible with the ACURATE neo2 valve per the commercial IFU based on the center's assessment of pre-procedure diagnostic imaging, and is deemed suitable for treatment with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) as confirmed by the Case Review Committee [CRC].
- •Subject (or legal representative) understands the study requirements and provides written informed consent (eg, IEC-approved ICF).
- •Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all study required follow-up visits.
排除标准
- •Subject has a previously implanted bioprosthesis in the aortic position.
- •Subject has a unicuspid or bicuspid aortic valve.
- •Subject has either of the following:
- •Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR
- •Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVI prosthesis.
- •Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or to the individual components of the study valve (nickel, titanium, processed porcine pericardium, polyethylene terephthalate [PET]).
- •Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
- •Subject is unwilling or unable to undergo study required follow-up visits.
结局指标
主要结局
Primary Endpoint:
时间窗: Index procedure
Proportion of patients who achieve target valve frame expansion\* at the end of the index procedure when following optimized procedural steps. \* "Target valve frame expansion" is defined as visual evidence of parallel commissure posts, as confirmed by an independent core laboratory evaluation of procedural angiogram.
次要结局
- Secondary Endpoint(30 days)