Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia, but the MitraClip® is also feasible in deep sedation. The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. The PMVR procedure, however, is typically performed under general anaesthesia. It has recently been shown in a first approach that performing the MitraClip® in deep sedation is feasible; however safety parameters and a direct comparison to general anaesthesia are still missing The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.
Study Type
OBSERVATIONAL
Enrollment
21
Number of patients with adverse Events
Evaluation of feasibility and safety of deep sedation instead of general anaesthesia
Time frame: patients will be followed for the duration of procedure until discharge, an expected average of 10 days
preparation and procedure time
Time frame: procedure
Overall time to discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Changes in 6-Minute Walk Test
Time frame: Baseline to 1 month after intervention
Changes in NYHA class
Time frame: Baseline to 1 month after intervention
Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Time frame: Baseline to 1 month after intervention
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