An observational study in Mitral Regurgitation, sponsored by LMU Klinikum. Recruiting at 30 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by LMU Klinikum · Observational
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.
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's planned enrollment of 400 is above the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →LMU Klinikum is the lead sponsor of 51 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients undergoing Implantation of Tendyne Mitral Valve System at the participating centres.
Exclusion Criteria:
all patients treated with a Tendyne Mitral Valve System
Device: Tendyne Mitral Valve System
Tendyne Mitral Valve System for mitral valve disease in a commercial setting
Rate of procedural success
Device success (structural and functional); absence of death, stroke, life-threatening bleeding, major vascular or cardiac structural complications, acute kidney injury, myocardial infarction, heart failure and valve-related dysfunction requiring repeat procedure
Time frame: 30 days
Rate of peri-procedural myocardial infarction
Myocardial infarction during the index procedure
Time frame: 1 day
Rate of conversion to open-heart surgery
Conversion to open-heart surgery during the index procedure
Time frame: 1 day
Rate of cardiac tamponade
Cardiac Tamponade during the index procedure
Time frame: 1 day
Rate of procedural mortality
Death during the index procedure
Time frame: 1 day
Rate of technical success (cumulative endpoint according to MVARC)
Absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery) Device success (according to MVARC): absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient \< 5 mmHg)
Time frame: 1 day
Rate of device success (cumulative endpoint according to MVARC)
Absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient \< 5 mmHg)
Time frame: 30 days, 1 year and 3 years
New York Heart Association (NYHA) functional class
class I - IV
Time frame: 30 days, 1 year and 3 years
6-minute walk distance (6MWD)
in m
Time frame: 30 days, 1 year and 3 years
BNP/NT-proBNP level
in pg/ml
Time frame: 30 days, 1 year and 3 years
Mitral regurgitation severity grade
grade 0/1+/2+/3+/4+
Time frame: 30 days, 1 year and 3 years
Left and right ventricular dimensions
left/right ventricular end-diastolic/-systolic diameter (in mm)
Time frame: 30 days, 1 year and 3 years
Left ventricular function
LVEF in percent
Time frame: 30 days, 1 year and 3 years
Right ventricular function
TAPSE in mm
Time frame: 30 days, 1 year and 3 years
Pulmonary artery pressure
in mmHg
Time frame: 30 days, 1 year and 3 years
Tricuspid regurgitation severity grade
grade 1-5
Time frame: 30 days, 1 year and 3 years
Transprosthetic gradient
in mmHg
Time frame: 30 days, 1 year and 3 years
Plan to share: No
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