NCT04782908

Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Heart Center Leipzig - University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.

Conditions

• Congestive Heart Failure
• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter tricuspid valve edge-to-edge repair	Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-30
• Completion: 2022-06-30
• First posted: 2021-03-04
• Last updated: 2021-04-19

Locations

1 site across 1 country: Germany