VDyne TriNova Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

The clinical trial is a prospective, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the VDyne TriNova Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Transcatheter tricuspid valve replacement with VDyne TriNova System in patients with severe or greater tricuspid regurgitation.

Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System

Transcatheter tricuspid valve replacement with Edwards EVOQUE System in patients with severe or greater tricuspid regurgitation.

Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System

Transcatheter tricuspid valve replacement with VDyne TriNova System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with Active Comparator EVOQUE device.

Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System

Subjects will undergo TTVR procedure with VDyne TriNova device and will continue to be managed on Optimal Medical Therapy (OMT).

Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).

Plazo: 30 days post-procedure

• Cardiovascular mortality
• Myocardial infarction
• All stroke
• New need for renal replacement therapy
• Severe bleeding
• Non-elective tricuspid valve re-intervention
• Major access site and vascular complications
• Major cardiac structural complications
• Device-related pulmonary embolism
• New arrhythmia or conduction disorder requiring permanent pacing

Plazo: 12 months post-procedure

No informado en este registro.

Plazo: 12 months post-procedure

Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) \* 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life.

Plazo: 12 months post-procedure

New York Heart Association (NYHA) Classification at 6 months. The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are:

Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Plazo: At 12 months and 24 months

Total number of deaths from any cause

Plazo: At 12 months and 24 months

Total number of patients requiring Right Ventricular Assist Device (RVAD) implantation or heart transplant

Plazo: At 12 months and 24 months

Total number of non-elective tricuspid valve re-interventions

Plazo: At 12 months and 24 months

Total number of patients with at least one hospital admission due to heart failure

Plazo: At 12 months and 24 months

Functional status improvement, as measured by 6-Minute Walk Test total distance walked. The 6-Minute Walk Test (6MWT) is a test that measures the total distance an individual can walk on a flat, hard surface in 6 minutes. It is commonly used to evaluate functional exercise capacity in patients with conditions including heart failure. The minimum score possible is 0, which would represent an inability to walk any distance. There is no maximum score, as a patient could theoretically walk any distance in 6 minutes though 800 meters considered the top reference range, which is what would be expected by elite athletes. Higher score indicate greater higher exercise capacity and lower scores indicate lower exercise capacity.

Plazo: At 6 months, 12 months and 24 months post-implant compared to baseline

Change in Tricuspid Regurgitation (TR) grade from baseline is measured. A 5-tier grading scheme will be used: mild, moderate, severe, massive and torrential. The change in TR grade is assessed using TransThoracic Echocardiogram (TTE) imaging.

Plazo: 12 months post-procedure

New York Heart Association (NYHA) Classification at 6 months. The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are:

Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Plazo: 12 months post-procedure

Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) \* 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life.

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation