NCT05628779

Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation

Evaluation of the Safety, Efficacy and Cost-effectiveness of Transcatheter Tricuspid Valve Repair in Patients With Severe Tricuspid Regurgitation in the Netherlands.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC alone in patients with symptomatic severe Tricuspid Regurgitation (TR) in the Netherlands.

Detailed description

Tricuspid valve regurgitation (TR) is a common heart valve disease associated with mortality, heart failure hospitalization (HHF) and a significant negative impact on quality of life (QoL). The prevalence of moderate or severe TR in the Netherlands is estimated at 0.55% and becoming more prevalent. Surgery is rarely performed, because in-hospital mortality is high and there is little evidence for the efficacy. The majority of patients does therefore entirely dependent on treatment with heart failure medication. However, a subset of these patients experience (progressive) symptoms of refractory congestive heart failure despite the SOC with heart failure medication. Transcatheter Tricuspid Valve repair (TTVr) offers several new strategies to address severe TR; one promising technique to treat patients with symptomatic severe TR is edge-to-edge tricuspid valve (TV) repair through leaflet approximation. Edge-to-edge TTVr may provide an elegant alternative treatment for many patients, because it is less burdensome due to the minimally invasive nature. Moreover, multiple single-arm trials already reported promising outcomes in terms of efficacy and safety, and the technique is very similar to Transcatheter Mitral Valve repair (TMVr), with yet proven feasibility, efficacy and safety. The aim of this study is to evaluate the safety, efficacy and cost-effectiveness of TTVr for patients with symptomatic severe TR despite the SOC and high/prohibitive surgical risk in the Netherlands.

Conditions

• Tricuspid Valve Regurgitation, Nonrheumatic
• Cardiac Catheterization
• Heart Failure, Right Sided
• Valve Regurgitation, Tricuspid

Interventions

Type	Name	Description
DEVICE	TriClip TTVr system (Abbott Vascular)	Edge-to-edge leaflet approximation for the tricuspid valve
DEVICE	PASCAL TTVr system (Edwards Lifesciences)	Edge-to-edge leaflet approximation for the tricuspid valve

Timeline

• Start date: 2022-12-12
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2022-11-29
• Last updated: 2024-02-16

Locations

6 sites across 1 country: Netherlands

Regulatory

• FDA-regulated device study