Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Tricuspid Valve Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEdwards TRIFORMIS RESILIA heart valve
Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
• Untreatable hypersensitivity to nitinol alloys (nickel and titanium)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant's average mean gradient measurement over time | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The New York Heart Association functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or anginal syndrome may be present even at rest. |
| Percentage of participant's freedom from all cause mortality | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from all cause mortality. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from cardiovascular mortality | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from cardiovascular mortality. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from valve-related mortality | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from valve-related mortality. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from tricuspid valve reintervention | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from a reoperation on their tricuspid valve. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from valve-related pulmonary embolism | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from valve-related pulmonary embolism. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from valve-related valve thrombosis | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from valve-related valve thrombosis. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from valve-related hemorrhage | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from valve-related hemorrhage. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from valve-related endocarditis | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from valve-related endocarditis. Time to events were estimated by Kaplan-Meier method. |
| Percentage of participant's freedom from tricuspid valve-related heart failure hospitalization | 1-, 2-, 3-, 4-, and 5- Years follow-up | Participants' freedom from tricuspid valve-related heart failure hospitalization. Time to events were estimated by Kaplan-Meier method. |
Countries
United States
Contacts
CONTACTAya Westbrook, PhD
Outcome results
None listed