Using ultrasound to reduce silent strokes during MitraClip implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The TCD-REDUCE study aims to evaluate the effectiveness of continuous transcranial Doppler sonography, known as sonolysis, in reducing ischemic stroke volume during MitraClip implantation for patients with mitral valve insufficiency. Participants will undergo cerebral MRI and neurological assessments before and after the procedure, while receiving sonolysis during the MitraClip implantation. The study will compare the median ischemic lesion volume detected on MRI between the sonolysis group and a control group. This approach is based on previous findings suggesting that sonolysis may lower the risk of cerebral ischemic lesions in other cardiac procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Charité-Campus Benjamin Franklin
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Christian H Nolte, Prof. — Charite University, Berlin, Germany
• Study coordinator: Tim Bastian Braemswig, MD
• Email: tim-bastian.braemswig@charite.de
• Phone: +49 30 450560624

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.