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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse Events | Evaluation of feasibility and safety of deep sedation instead of general anaesthesia | patients will be followed for the duration of procedure until discharge, an expected average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| preparation and procedure time | procedure | |
| Overall time to discharge | Participants will be followed for the duration of hospital stay, an expected average of 10 days | |
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Inclusion Criteria:
Exclusion Criteria:
-
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Patients with severe mitral regurgitation characterized by trans-thoracic and trans-esophageal echocardiography undergoing PMVR using the MitraClip® system
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| Name | Affiliation | Role |
|---|---|---|
| Tienush Rassaf, MD | Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf | Principal Investigator |
| Malte Kelm, MD | Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24909413 | Derived | Rassaf T, Balzer J, Zeus T, Rammos C, Shayganfar S, Hall SV, Wagstaff R, Kelm M. Safety and efficacy of deep sedation as compared to general anaesthesia in percutaneous mitral valve repair using the MitraClip system. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):E38-42. doi: 10.1002/ccd.25570. Epub 2014 Jul 4. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Changes in 6-Minute Walk Test |
| Baseline to 1 month after intervention |
| Changes in NYHA class | Baseline to 1 month after intervention |
| Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) | Baseline to 1 month after intervention |