Multi-center, Single-arm, Observational Study Assessing Real-world Safety and Performance of the TRIFORMIS RESILIA Tricuspid Valve for Surgical Tricuspid Valve Replacement (TRIBLAZE Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Participant's average mean gradient measurement over time
研究概览
简要总结
TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical tricuspid heart valve, Model 11300T.
详细描述
Subjects in the TRIBLAZE study will be enrolled at up to 15 sites in the United States. The population will be participants requiring replacement of their native or prosthetic tricuspid valve.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older
- •Indication for TRIFORMIS valve implant for native or prosthetic valve dysfunction
- •Provide written informed consent prior to the 30-day imaging follow-up
- •Willing and able to return for scheduled follow-up visits
排除标准
- •Untreatable hypersensitivity to nitinol alloys (nickel and titanium)
结局指标
主要结局
Participant's average mean gradient measurement over time
时间窗: 1 Year
Mean gradient is the average flow of blood through the tricuspid valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Participant's average peak gradient measurement over time
时间窗: 1 Year
Peak gradient is the maximum value measured of flow of blood through the tricuspid valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Participant's average Effective Orifice Area (EOA) measurement over time
时间窗: 1 Year
Effective orifice area represents the cross-sectional area of the blood flow downstream of the tricuspid valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
Participant's amount of tricuspid valvular regurgitation measurement over time
时间窗: 1 Year
Valvular regurgitation occurs when the valve in the heart does not close tightly, allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation, 1 = a trace of regurgitation, 2 = mild regurgitation, 3 = moderate regurgitation, and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.
Participant's right ventricular function over time
时间窗: 1 Year
Right ventricular function is the heart's ability to pump deoxygenated blood through the pulmonary circulation into the lungs. Right ventricular function is assessed via echocardiography. It is assessed on a scale of: Normal, Mild dysfunction, Moderate dysfunction, Moderate-severe dysfunction, or Severe dysfunction.
Participant's amount of paravalvular leak over time
时间窗: 1 Year
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 1 year
时间窗: Baseline and 1 Year
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated, disease-specific health status tool for patients with heart failure. It measures symptoms, physical and social limitations, and quality of life over the previous two weeks. Scores range from 0 to 100, where higher numbers indicate better health and fewer symptoms and lower numbers indicate wore health and more symptoms.
次要结局
- Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class(Baseline, 1 month, 1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from all cause mortality(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from cardiovascular mortality(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from valve-related mortality(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from tricuspid valve reintervention(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from valve-related pulmonary embolism(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from valve-related valve thrombosis(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from valve-related hemorrhage(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from valve-related endocarditis(1-, 2-, 3-, 4-, and 5- Years follow-up)
- Percentage of participant's freedom from tricuspid valve-related heart failure hospitalization(1-, 2-, 3-, 4-, and 5- Years follow-up)