TriClip Japan Post-Approval Study

A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.

The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following commercial approval in Japan.

Tricuspid Regurgitation (TR) is an abnormal condition which has both short-term and long-term consequences. TR decreases forward cardiac output and raises right-sided systemic venous pressures. This physiology will often result in hepatorenal congestion and dysfunction and, in addition, cause edema and ascites. The retrograde cardiac blood flow and volume loading also leads to further tricuspid dilatation exacerbating regurgitation over time.

The TriClip System is indicated for TR reduction in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are under the following conditions, as determined by a heart team:

• Patients with left-sided disease must be well treated according to the Japan guideline
• Patients for whom tricuspid valve surgery is not the optimal treatment
• Patients in whom transcatheter edge-to-edge valve repair is clinically appropriate

The objective of the TriClip Japan post-approval study is to confirm the safety and efficacy of the TriClip System for the treatment of symptomatic severe tricuspid regurgitation in a contemporary, real-world setting in the Japanese population, using the commercially available device in accordance with its approved indications for use.

Inclusion Criteria:

• Subjects are eligible to receive the TriClip System per the current approved indications for use (IFU)
• Subjects provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.

Exclusion Criteria:

• There are no exclusion criteria
• Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.