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STRONG: Silent sTROke duriNG MitraClip Implantation

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT03104556
Collaborator
(none)
54
Enrollment
1
Location
43.7
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip
    Actual Study Start Date :
    Apr 14, 2017
    Actual Primary Completion Date :
    Dec 3, 2020
    Actual Study Completion Date :
    Dec 3, 2020

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation [0-72h]

    2. Localizations of cerebral lesions after MitraClip-procedure [0-72h]

    3. Incidence of peri- and postprocedural stroke [0-72h]

    4. Incidence of delirium after MitraClip [0-72h]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charite Berlin Germany

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Chair: Alexander Lauten, Prof. Dr., Charite Kardiologie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexander Lauten, Prof. Dr. med. A. Lauten, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03104556
    Other Study ID Numbers:
    • STRONG-MitraClip 01
    First Posted:
    Apr 7, 2017
    Last Update Posted:
    Dec 16, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Mitral Valve Insufficiency

    Study Results

    No Results Posted as of Dec 16, 2020