Tendyne European Experience Registry — TENDER  

Mitral Regurgitation Clinical Trial

Official title: TENDyne European expeRience Registry

Status Recruiting

Clinical Trial Summary

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

Clinical Trial Description

Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available.

TENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes. ;

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

• NCT number: NCT04898335
• Study type: Observational [Patient Registry]
• Source: Klinikum der Universitaet Muenchen
• Contact: Joerg Hausleiter, MD
• Phone: 0049894400
• Email: joerg.hausleiter@med.uni-muenchen.de
• Status: Recruiting
• Start date: April 15, 2021
• Completion date: December 31, 2027