Table 2.

Ongoing trials of transcatheter treatment of tricuspid regurgitation with dedicated devices using the edge-to-edge technique

Trial	TriClip System
TRILUMINATE Pivotal	The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation, who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare TriClip to medical therapy.
bRIGHT	An observational single-arm, multicenter, real-world study evaluating severe tricuspid regurgitation in 200 patients treated with the TriClip System.
TRI-FR	Evaluation of tricuspid valve percutaneous repair system compared to conventional pharmacological treatment in the treatment of severe secondary tricuspid disorders in patients unsuitable for surgical isolated correction of tricuspid regurgitation.
	PASCAL System
CLASP TR EFS	Early feasibility study of the PASCAL system for tricuspid valve repair in patients with tricuspid insufficiency. Enrollment is currently limited to patients in the United States.
CLASP II TR	Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the PASCAL System and OMT compared to OMT alone in patients with tricuspid regurgitation.
TriCLASP	European prospective, multicenter post-market study of transcatheter repair of tricuspid regurgitation.

OMT, optimal medical therapy.