Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 主要终点
- Composite 12-Month Endpoint: All-cause mortality, heart failure hospitalization, tricuspid valve re-intervention
研究概览
简要总结
The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid regurgitation (TR).
详细描述
This study is a prospective, multi-center randomized (2:1) controlled pivotal trial to evaluate the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System compared to the Edwards EVOQUE TTVR System for the treatment of symptomatic subjects with severe or greater tricuspid regurgitation (TR).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 90 years of age at the time of the study procedure.
- •Symptomatic TR despite being adequately treated with OMT by the Local Heart Team for at least 30 days prior to the time of study consent.
- •Severe, massive or torrential tricuspid regurgitation determined by qualifying echocardiogram using the 5-grade classification.
- •Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local Heart Team and confirmed by the patient selection committee.
- •Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits.
- •Anatomically suitable for the Laplace TTVR system.
排除标准
- •Estimated life expectancy of less than 12 months.
- •Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months.
- •Severe renal insufficiency defined as eGFR <25 mL/min or requiring chronic renal replacement therapy at the time of screening committee review.
- •Current history (within last 5 years) of illicit drug use.
- •Stroke or other major cerebrovascular event within 90-days prior to index procedure.
- •Current or planned pregnancy within next 12 months for women of childbearing potential.
- •Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
- •Anatomically unsuitable for the Laplace TTVR System
研究组 & 干预措施
Laplace TTVR System Single Arm Cohort
Transcatheter tricuspid valve replacement with Laplace TTVR System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with the Active Comparator EVOQUE TTVR and are suboptimal T-TEER candidates.
干预措施: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System (Device)
Laplace TTVR System
Transcatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR.
干预措施: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System (Device)
Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR.
干预措施: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System (Device)
结局指标
主要结局
Composite 12-Month Endpoint: All-cause mortality, heart failure hospitalization, tricuspid valve re-intervention
时间窗: 12 months post-procedure
12-month composite of all-cause mortality, heart failure hospitalization, tricuspid valve re-intervention
Composite of major adverse events (MAEs)
时间窗: 30 days post-procedure
A composite of major adverse events (MAEs) at 30 days consisting of the following components: * Cardiovascular mortality * Myocardial infarction (MI) * All stroke * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\]) * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * New arrhythmia or conduction disorder requiring permanent pacing
次要结局
- Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) ≥ 10 points from baseline to 12 months(12 months post-procedure)