Silent sTROke duriNG MitraClip Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-14

Study Completion Date

2020-12-03

Brief Summary

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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

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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.

Conditions

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Mitral Regurgitation Silent Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Alexander Lauten

Prof. Dr. med. A. Lauten

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Lauten, Prof. Dr.

Role: STUDY_CHAIR

Charite Kardiologie

Locations

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Charite

Berlin, , Germany

Site Status

Countries

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Germany

References

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Braemswig TB, Kusserow M, Bellmann B, Beckhoff F, Reinthaler M, von Rennenberg R, Erdur H, Scheitz JF, Galinovic I, Villringer K, Leistner DM, Audebert HJ, Endres M, Landmesser U, Haeusler KG, Fiebach JB, Lauten A, Rillig A, Nolte CH. New Cerebral Microbleeds After Catheter-Based Structural Heart Interventions: An Exploratory Analysis. J Am Heart Assoc. 2023 Feb 7;12(3):e8189. doi: 10.1161/JAHA.122.027284. Epub 2023 Feb 3.

Reference Type DERIVED

PMID: 36734351 (View on PubMed)

Other Identifiers

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STRONG-MitraClip 01

Identifier Type: -

Identifier Source: org_study_id