Clinical trial NCT02023762: Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
Official title: Safety and Feasibility of Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Local Anaesthesia
Percutaneous Repair
Keywords: mitral regurgitation
local anaesthesia
percutaneous repair
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe mitral regurgitation characterized by trans-thoracic and trans-esophageal echocardiography undergoing PMVR using the MitraClip® system

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* severe mitral regurgitation
* PMVR using the MitraClip® system

Exclusion Criteria:

-

Primary outcomes:
measure: Number of patients with adverse Events
timeFrame: patients will be followed for the duration of procedure until discharge, an expected average of 10 days
Secondary outcomes:
measure: preparation and procedure time
timeFrame: procedure
measure: Overall time to discharge
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Changes in 6-Minute Walk Test
timeFrame: Baseline to 1 month after intervention
measure: Changes in NYHA class
timeFrame: Baseline to 1 month after intervention
measure: Changes in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
timeFrame: Baseline to 1 month after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
name: Tienush Rassaf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Dusseldorf
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
citation: 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.