Status:
ACTIVE_NOT_RECRUITING
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
Lead Sponsor:
Abbott Medical Devices
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
Detailed Description
The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support ...
Eligibility Criteria
Inclusion
- Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
- Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
- Patient provides written informed consent prior to any study-specific procedure.
Exclusion
- Patient is in another clinical study that may impact the follow-up or results of this study.
- Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
- Patient is under the age of 18 or age of legal consent.
- Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04818502
Start Date
May 4 2021
End Date
May 31 2029
Last Update
June 12 2024
Active Locations (36)
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1
Kepler University Hospital
Linz, Austria
2
UZ Gasthuisberg
Leuven, Belgium
3
University Hospital Olomouc
Olomouc, Czechia
4
IKEM Prague
Prague, Czechia