TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation

Study Overview
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Brief Summary
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The primary goal of the TCD-REDUCE study is to demonstrate the effectiveness of continuous transcranial Doppler sonography (sonolysis) on the reduction of the ischemic stroke volume during MitraClip implantation.

Detailed Description
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Cardiac procedures are associated with new cerebral ischemic lesions detected on diffusion-weighted MRI (Bendszus et al., 2006). A previous study suggests that sonolysis (continuous transcranial Doppler sonography using a 2-MHz diagnostic probe) can reduce the risk of new cerebral ischemic lesions during carotid endarterectomy and carotid angioplasty / stenting (Skoloudik et al., 2015). Currently, it is unknown whether sonolysis can also reduce the risk of new cerebral ischemic lesions during MitraClip implantation - a percutaneous treatment option in patients with moderate / severe mitral regurgitation. In this study, patients will receive cerebral MRI and clinical neurological / neuropsychological examination before and after MitraClip implantation. During MitraClip implantation, all patients will receive continuous transcranial Doppler sonography using a 2-MHz diagnostic probe with maximal diagnostic energy administered through either the left or the right transtemporal window (computer-generated 1:1 randomization). The primary endpoint is the median ischemic lesion volume detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis group and in the control group.

Official Title
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TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Procedure: Sonolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines. Exclusion Criteria: contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia) pregnancy unable to consent no transtemporal window

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: PROBE
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonolysis group<br>Cerebral hemisphere with sonolysis during MitraClip implantation. | Procedure: Sonolysis<br>* Continuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy<br>|
| No Intervention: Control group<br>Cerebral hemisphere without sonolysis during MitraClip implantation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke volume | median volume (in ml) of new ischemic lesions detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis and in the control group | 0-5 days after the MitraClip Implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diffusion-weighted MRI lesions | new ischemic lesions (occurrence, number and location) detected on diffusion-weighted MRI after MitraClip implantation | 0-5 days after the MitraClip Implantation | 
| intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH) | new ICH and / or SAH detected on T2*-weighted MRI after MitraClip implantation | 0-5 days after the MitraClip Implantation | 
| cerebral microbleeds (CMB) | new cerebral microbleeds detected on T2*-weighted MRI after MitraClip implantation (occurrence, number and location) | 0-5 days after the MitraClip Implantation | 
| clinically overt stroke | new clinically overt stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) after MitraClip implantation | (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation | 
| functional outcome | functional outcome will be evaluated using the modified Rankin scale (mRS). The mRS ranges from 0 to 6 with 0 indicating no functional deficit (best score) and 6 indicating deaths (worst score). | (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation | 
| cognitive outcome during hospital stay | cognitive outcome will be evaluated using the Montreal Cognitive Assessment (MoCA) | 0-5 days after the MitraClip Implantation | 
| cognitive outcome at follow-up | cognitive outcome will be evaluated using the Telephone Interview for Cognitive Status (TICS) | 3 months after MitraClip implantation | 
| delirium | delirium will be evaluated using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) | 0-5 days after the MitraClip Implantation | 
| length of hospital stay (duration of hospitalization for the MitraClip implantation) | days of hospital stay from admission to hospital to discharge from hospital including direction of discharge (home, another hospital) | length of hospital stay (up to 3 months after MitraClip implantation) | 
| mortality | mortality | up to 3 months after MitraClip implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MitraClip, Sonolysis, Stroke