The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy, who have been determined by the site's local heart team to be at intermediate or greater estimated risk for mortality and morbidity with tricuspid valve surgery.
详细描述
A prospective, multi-center, randomized, controlled, pivotal study of the MIA Percutaneous Tricuspid Annuloplasty System (MIA-T) in symptomatic subjects with severe (≥3) TR despite optimal medical therapy.
The study will randomize eligible subjects in two (2) cohorts at up to 40 sites.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has severe functional TR (≥ 3). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
- •In the judgment of the site's local heart team patient is at intermediate or greater risk for morbidity & mortality with tricuspid valve surgery, and has been adequately treated per applicable standards with optimized medical therapy for the treatment of TR (e.g. diuretics) and stable for at least 30 days prior to enrollment.
- •New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
排除标准
- •Systolic pulmonary artery pressure (sPAP) > 70 mmHg or > 5 wood units (WU) despite vasodilator therapy
- •Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
- •Previous tricuspid valve repair or replacement (transcatheter or surgical approach)
- •Subjects with concomitant left-sided valve disease will have the option of receiving a left-sided intervention (e.g. TMVR or TAVR) and waiting 60 days prior to being reassessed for the study
- •Myocardial infarction (MI), known unstable angina, symptomatic coronary artery disease (CAD) where revascularization is possible within 60 days prior to enrollment
- •Anatomy that precludes safe placement of anchors around the annulus
- •Hemodynamic instability defined as systolic pressure < 90 mmHg requiring pressor support within the last 30 days
- •Echo Criteria -
- •Subject has severe functional TR (determined by the ICL). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
- •No presence of Cardiac Implantable Electronic Devices (CIED) leads causing the TR
- •No significant annular calcification
- •Left Ventricular Ejection Fraction (LVEF) ≥ 20%
研究组 & 干预措施
Randomized Cohort TEER
MIA-T vs. TEER
干预措施: MIA_T Device (Device)
Single Arm Cohort
MIA-T
干预措施: MIA_T Device (Device)
Roll-in
MIA-T device for physicians training prior to initiating randomized cohort enrollment.
干预措施: MIA_T Device (Device)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: 12 months
Composite endpoint of the following components: * All-cause mortality * Tricuspid valve intervention (percutaneous or surgery) * Heart Failure Hospitalization
Primary Safety Endpoint
时间窗: 30 days
Freedom from MAE, including: * Cardiovascular mortality * New Onset Renal Failure * Endocarditis requiring surgery * Non-elective cardiovascular surgery for device-related AE post-index procedure
Primary Efficacy Endpoint
时间窗: 12 months
Composite endpoint of the following components: * All-cause mortality * Tricuspid valve intervention (percutaneous or surgery) * Heart Failure Hospitalization
Primary Safety Endpoint
时间窗: 30 days
Freedom from MAE, including: * Cardiovascular mortality * New Onset Renal Failure * Endocarditis requiring surgery * Non-elective cardiovascular surgery for device-related AE post-index procedure
次要结局
- Freedom from all-cause mortality at all study timepoints(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Freedom from heart failure hospitalizations at all study timepoints(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Clinical Success Rate(1Month)
- Intraprocedural Success Rate(1Month)
- Freedom from Major Adverse Events (MAE) at all study time points.(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Prevalence of Device or Procedure-Related Adverse Events (AE)(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Core Lab assessment of change in other pertinent echo(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in NT-proBNP(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in gamma-GTP(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in eGFR(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in MELD score (liver function)(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in SF-36 QoL scores(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Intraprocedural Success Rate(1Month)
- Change in NT-proBNP(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Freedom from all-cause mortality at all study timepoints(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Freedom from heart failure hospitalizations at all study timepoints(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Clinical Success Rate(1Month)
- Freedom from Major Adverse Events (MAE) at all study time points.(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in MELD score (liver function)(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Prevalence of Device or Procedure-Related Adverse Events (AE)(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Core Lab assessment of change in other pertinent echo(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in gamma-GTP(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in eGFR(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)
- Change in SF-36 QoL scores(1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years)