Mitral Regurgitation
Conditions
Keywords
mitral regurgitation, Tendyne, transcatheter mitral valve replacement
Brief 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.
Interventions
Tendyne Mitral Valve System for mitral valve disease in a commercial setting
Sponsors
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting * Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements
Exclusion criteria
* Patients not providing written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of procedural success | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of peri-procedural myocardial infarction | 1 day | Myocardial infarction during the index procedure |
| Rate of conversion to open-heart surgery | 1 day | Conversion to open-heart surgery during the index procedure |
| Rate of cardiac tamponade | 1 day | Cardiac Tamponade during the index procedure |
| Rate of procedural mortality | 1 day | Death during the index procedure |
| Rate of technical success (cumulative endpoint according to MVARC) | 1 day | 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) |
| Rate of device success (cumulative endpoint according to MVARC) | 30 days, 1 year and 3 years | 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) |
| New York Heart Association (NYHA) functional class | 30 days, 1 year and 3 years | class I - IV |
| Transprosthetic gradient | 30 days, 1 year and 3 years | in mmHg |
| BNP/NT-proBNP level | 30 days, 1 year and 3 years | in pg/ml |
| Mitral regurgitation severity grade | 30 days, 1 year and 3 years | grade 0/1+/2+/3+/4+ |
| Right ventricular function | 30 days, 1 year and 3 years | TAPSE in mm |
| Pulmonary artery pressure | 30 days, 1 year and 3 years | in mmHg |
| Left and right ventricular dimensions | 30 days, 1 year and 3 years | left/right ventricular end-diastolic/-systolic diameter (in mm) |
| Left ventricular function | 30 days, 1 year and 3 years | LVEF in percent |
| Tricuspid regurgitation severity grade | 30 days, 1 year and 3 years | grade 1-5 |
| 6-minute walk distance (6MWD) | 30 days, 1 year and 3 years | in m |
Countries
Austria, Belgium, France, Germany, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom
Contacts
Primary ContactJoerg Hausleiter, MD
Backup ContactMirjam Wild, MD
Outcome results
None listed