Silent sTROke duriNG MitraClip Implantation (STRONG)

Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip

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.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation; Silent Stroke

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 Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total amount of high intensity signals (HITS) during the predefined procedural intervals	during the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation	0-72h
Localizations of cerebral lesions after MitraClip-procedure	0-72h
Incidence of peri- and postprocedural stroke	0-72h
Incidence of delirium after MitraClip	0-72h

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Chair: Alexander Lauten, Prof. Dr., Charite Kardiologie

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2017
• Primary Completion (ACTUAL): December 3, 2020
• Study Completion (ACTUAL): December 3, 2020

Study Registration Dates

• First Submitted: April 1, 2017
• First Submitted That Met QC Criteria: April 1, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 13, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Valve Diseases; Stroke; Mitral Valve Insufficiency
• Other Study ID Numbers: STRONG-MitraClip 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No