NCT04898335

Tendyne European Experience Registry

TENDyne European expeRience Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Tendyne Mitral Valve System	Tendyne Mitral Valve System for mitral valve disease in a commercial setting

Timeline

• Start date: 2021-04-15
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2021-05-24
• Last updated: 2021-05-24

Locations

30 sites across 10 countries: Austria, Belgium, France, Germany, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study