Silent sTROke duriNG MitraClip Implantation

Completed

• Conditions: Mitral Regurgitation; Silent Stroke

• Registration Number: NCT03104556
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2017-04-01
• Study First Submitted QC: 2017-04-01
• Study First Posted: 2017-04-07
• Study Start: 2017-04-14
• Status Verified: 2020-12
• Primary Completion: 2020-12-03
• Study Completion: 2020-12-03
• Last Update Submitted: 2020-12-13
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total amount of high intensity signals (HITS) during the predefined procedural intervals	during the procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Charite; 🇩🇪 Berlin, Germany