TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation (TCD-REDUCE)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Mitral Valve Insufficiency

Treatments: Procedure: Sonolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04384198

EA4/193/19

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Sonolysis group

Experimental group

Description:

Cerebral hemisphere with sonolysis during MitraClip implantation.

Treatment:

Procedure: Sonolysis

Control group

No Intervention group

Description:

Cerebral hemisphere without sonolysis during MitraClip implantation.