At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tendyne Mitral Valve System (device)
- How long the study runs
- Study runs about 80 months (dates as stated)
- About the drug or intervention
- Tendyne Mitral Valve System — device: Tendyne Mitral Valve System for mitral valve disease in a commercial setting
- Patient visit burden
- Not specified by the sponsor
In plain English
This registry collects information from people across Europe who have been treated with the Tendyne Mitral Valve System for mitral valve disease. The mitral valve is a valve in the heart, and mitral regurgitation means this valve does not close properly, letting blood leak backwards. The sponsor is LMU Klinikum.
Who can take part
- People treated with the Tendyne Mitral Valve System for mitral valve disease in a normal (commercial) care setting
- People who give written informed permission (consent) to take part, following the study rules and all national laws
Who may not be able to
- People who do not give written informed permission (consent) to take part
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visits, how long it lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 400
- Started
- 2021-04-15
- Last checked
- 2021-05
Plain English Summary
What is this study?
- • Testing a new treatment for mitral regurgitation
- • Clinical study - 400 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with mitral regurgitation
Where?
- • London - Royal Brompton London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting
- ✓Patients providing written agreement to take part in compliance with the protocol, the ICH-GCP and all national legal and...
Who cannot take part
- ✗Patients not providing written agreement to take part
See the full criteria
Where Is This Study? (1 UK site)
Royal Brompton London
London, United Kingdom
How to Get in Touch
Joerg Hausleiter, MD
Sponsor contactCONTACT
Mirjam Wild, MD
Sponsor contactCONTACT