Status:
RECRUITING
Tendyne European Experience Registry
Lead Sponsor:
LMU Klinikum
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients not providing written informed consent
Key Trial Info
Start Date :
April 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04898335
Start Date
April 15 2021
End Date
December 31 2027
Last Update
May 24 2021
Active Locations (30)
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1
Universitaetsklinikum Linz
Linz, Austria
2
Universitaetsklinikum Wien
Vienna, Austria
3
UZ Leuven
Leuven, Belgium
4
CHU de Bordeaux
Bordeaux, France