Using ultrasound to reduce silent strokes during MitraClip implantation
TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation
This study is testing if using ultrasound during MitraClip surgery can help reduce the risk of silent strokes in patients with mitral valve problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT04384198 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with moderate to severe mitral regurgitation who are eligible for MitraClip implantation as determined by an interdisciplinary heart team.
Not a fit: Patients with contraindications to MRI, such as those with pacemakers or claustrophobia, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of silent strokes in patients undergoing MitraClip implantation.
How similar studies have performed: Previous studies have shown success with sonolysis in reducing ischemic lesions during other cardiac procedures, suggesting potential for this approach in MitraClip implantation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Berlin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.