TransCranial Doppler for REDUCtion of 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

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-13

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Mitral Valve Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

PROBE

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sonolysis group

Cerebral hemisphere with sonolysis during MitraClip implantation.

Group Type EXPERIMENTAL

Sonolysis

Intervention Type PROCEDURE

Continuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy

Control group

Cerebral hemisphere without sonolysis during MitraClip implantation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sonolysis

Continuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No