Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
Safety and Feasibility of Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
1 other identifier
observational
21
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 12, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedDecember 30, 2013
December 1, 2013
1.9 years
December 12, 2013
December 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
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
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
Eligibility Criteria
Patients with severe mitral regurgitation characterized by trans-thoracic and trans-esophageal echocardiography undergoing PMVR using the MitraClip® system
You may qualify if:
- severe mitral regurgitation
- PMVR using the MitraClip® system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 24909413DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tienush Rassaf, MD
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
- STUDY CHAIR
Malte Kelm, MD
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study Record Dates
First Submitted
December 12, 2013
First Posted
December 30, 2013
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 30, 2013
Record last verified: 2013-12