Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.

Analysis includes patients who had an MAE or who were followed for at least 30 days. Patients may experience more than one MAE.

Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

Per device analysis as participants may have more than one device attempted

Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.

The outcome is reported where data are available.

Procedural success without MAEs at 30 days.

The outcome is reported where data are available.

Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.

The outcome is reported where data are available.

Tricuspid regurgitation (TR) is measured by transthoracic echocardiogram (TTE) at each visit using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

NYHA Functional Classification - The stages of heart failure:

Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.

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

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

Mean distance in meters walked during Six Minute Walk Test (6MWT) at each follow-up visit compared to baseline. 6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

Mean KCCQ score at each follow-up visit compared to baseline. The KCCQ 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. Scores range from 0-100, in which higher scores reflect better health status.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

Mean change in SF-36 mental score at each follow-up visit compared to baseline compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

Mean change in SF-36 physical score at each follow-up visit compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

Mean change in body weight in kilograms at each follow-up visit compared to baseline.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

Mean change in left ankle circumference in centimeters at each follow-up visit compared to baseline.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

Mean change in right ankle circumference in centimeters at each follow-up visit compared to baseline.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.

The edema grading scale measures how quickly the dimple goes back to normal (rebound) after a pitting test. The scale includes:

Grade 1: Immediate rebound with 0 to 2 millimeter (mm) pit. Grade 2: Less than 15-second rebound with 3 to 4 mm pit. Grade 3: Rebound greater than 15 seconds but less than 60 seconds with 5 to 6 mm pit.

Grade 4: Rebound between 2 to 3 minutes with an 8 mm pit.

The outcome is reported where data are available. Follow-up in the TRISCEND study is ongoing. Results beyond 6 months will be posted after completion of full follow-up.