Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Total amount of high intensity signals (HITS) during the predefined procedural intervals
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The MitraClip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without clinical manifestations is high. The aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.
Detailed Description
Mitral regurgitation is the second most common manifestation of valvular heart disease in adults. Surgical reconstruction is considered treatment of choice. For some patients the surgical risk is to high an operation is refused. For those Patients the MitraClip system (Abbott Vascular, Menlo Park, CA, USA) offers a much less invasive treatment option. Occurrence of a stroke or transient ischemic attack (TIA) is one of the potential complications during this procedure. 1% of all patients have an acute stroke. The number of new ischemic lesions without clinical manifestations is much higher (up to 85%). The impact of these lesions on the global cognitive function is unclear. The aim of this study is to determine the frequency of cerebral embolisms related to predefined procedural intervals and postprocedural cerebral lesions using Transcranial Doppler ultrasound and magnetic resonance imaging. Furthermore we want to study the correlation between cerebral embolisms seen as high intensity signals in transcranial duplex ultrasound and cerebral lesions seen in the cMRT. The results should build a basis for further studies that want to reduce the amount of cerebral lesions.
Investigators
Alexander Lauten
Prof. Dr. med. A. Lauten
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing a MitraClip-procedure due to mitral regurgitation in the study period Written consent Procedure recommended by a Cardio-Thoracic Surgery Conference
Exclusion Criteria
- •Patients who are not able to give consent Patients \<18 years Participation in another interventional Trial Pregnant or lactating females Contraindication to MRI
Outcomes
Primary Outcomes
Total amount of high intensity signals (HITS) during the predefined procedural intervals
Time Frame: during the procedure
Secondary Outcomes
- Incidence of peri- and postprocedural stroke(0-72h)
- Incidence of delirium after MitraClip(0-72h)
- Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation(0-72h)
- Localizations of cerebral lesions after MitraClip-procedure(0-72h)