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Completed

NCT Number: NCT03104556

Silent sTROke duriNG MitraClip Implantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total amount of high intensity signals (HITS) during the predefined procedural intervals

    Time frame: during the procedure

Secondary outcomes

  1. Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation

    Time frame: 0-72h

  2. Localizations of cerebral lesions after MitraClip-procedure

    Time frame: 0-72h

  3. Incidence of peri- and postprocedural stroke

    Time frame: 0-72h

  4. Incidence of delirium after MitraClip

    Time frame: 0-72h

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip

Acronym: STRONG

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2017
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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