Clinical trial NCT03104556: Silent sTROke duriNG MitraClip Implantation
Official title: Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Silent Stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing the MitraClip between April 2017 December 2019 procedure due to a severe mitral regurgitation will be enrolled in our study. All patients will be assigned to either a surgical procedure or the MitraClip-procedure by an interdisciplinary heart team according to current guidelines irrespective of this study.

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.

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

Primary outcomes:
measure: Total amount of high intensity signals (HITS) during the predefined procedural intervals
timeFrame: during the procedure
Secondary outcomes:
measure: Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation
timeFrame: 0-72h
measure: Localizations of cerebral lesions after MitraClip-procedure
timeFrame: 0-72h
measure: Incidence of peri- and postprocedural stroke
timeFrame: 0-72h
measure: Incidence of delirium after MitraClip
timeFrame: 0-72h
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite
Study officials:
affiliation: Charite Kardiologie
name: Alexander Lauten, Prof. Dr.
role: STUDY_CHAIR
References: