TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation

NCT04384198 | Unknown

• 1 other identifier: EA4/193/19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mitral Valve Insufficiency

Keywords

MitraClip; Sonolysis; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• diffusion-weighted MRI lesions

  0-5 days after the MitraClip Implantation

• intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH)

  0-5 days after the MitraClip Implantation

• cerebral microbleeds (CMB)

  0-5 days after the MitraClip Implantation

• clinically overt stroke

  (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation

• functional outcome

  (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation

Study Arms (2)

Sonolysis group

EXPERIMENTAL

Cerebral hemisphere with sonolysis during MitraClip implantation.

Procedure: Sonolysis

Control group

NO INTERVENTION

Cerebral hemisphere without sonolysis during MitraClip implantation.

Interventions

Sonolysis PROCEDURE

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

Sonolysis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines.

You may not qualify if:

• contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia)
• pregnancy
• unable to consent
• no transtemporal window

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Berlin Institute of Health: collaborator

Study Sites (1)

Charité-Campus Benjamin Franklin

Berlin, 12200, Germany

RECRUITING

Related Publications (1)

• Skoloudik D, Kuliha M, Hrbac T, Jonszta T, Herzig R; SONOBUSTER Trial Group. Sonolysis in Prevention of Brain Infarction During Carotid Endarterectomy and Stenting (SONOBUSTER): a randomized, controlled trial. Eur Heart J. 2016 Oct 21;37(40):3096-3102. doi: 10.1093/eurheartj/ehv492. Epub 2015 Sep 28.

  PMID: 26417059 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency; Stroke

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Christian H Nolte, Prof.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Bastian Braemswig, MD

CONTACT

+49 30 450560624; tim-bastian.braemswig@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Christian H. Nolte

Model Details: PROBE

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 12, 2020
• Study Start: August 13, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)