Procedural success without MAEs at 30 days. (MAEs: cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention and major access site and vascular complications)

Race and Ethnicity were not collected from any participant.

NYHA 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 European System for Cardiac Operative Risk Evaluation (EuroSCORE II) is a risk model which allows the calculation of the risk of death after a heart operation. The higher the score, the higher the risk of an adverse outcome.

EuroSCORE II risk levels are as follows:

<8: Low Risk

8-10: Moderate Risk

>10 High Risk

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.

The intention-to-treat (ITT) population includes all patients who signed informed consent, met eligibility criteria, and in whom the study procedure has been attempted (i.e. at least skin incision to introduce the FORMA System).

Device success with evidence of TR reduction as evidenced by a relative reduction in EROA of ≥ 30% from baseline to discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge.

The as-treated population is a subset of ITT population and includes all patients in whom the study device is implanted and remains in position at the time of the patient's exit from the procedure room.

Procedural success without MAEs at 30 days. (MAEs: cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention and major access site and vascular complications)

The as-treated population is a subset of ITT population and includes all patients in whom the study device is implanted and remains in position at the time of the patient's exit from the procedure room.