Silent sTROke duriNG MitraClip Implantation

Mitral Regurgitation Clinical Trial

— STRONG  

Official title:

Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104556
• Other study ID #: STRONG-MitraClip 01
• Status: Completed
• Start date: April 14, 2017
• Est. completion date: December 3, 2020

Study information

• Verified date: December 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Silent Stroke
• Stroke

Locations

Country	Name	City	State
Germany	Charite	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of high intensity signals (HITS) during the predefined procedural intervals		during the procedure
Secondary	Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation		0-72h
Secondary	Localizations of cerebral lesions after MitraClip-procedure		0-72h
Secondary	Incidence of peri- and postprocedural stroke		0-72h
Secondary	Incidence of delirium after MitraClip		0-72h