Silent sTROke duriNG MitraClip Implantation
STRONG
1 other identifier
observational
54
1 country
1
Brief Summary
The MitraClip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without clinical manifestations is high. The aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2020
CompletedDecember 16, 2020
December 1, 2020
3.6 years
April 1, 2017
December 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Total amount of high intensity signals (HITS) during the predefined procedural intervals
during the procedure
Secondary Outcomes (4)
Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation
0-72h
Localizations of cerebral lesions after MitraClip-procedure
0-72h
Incidence of peri- and postprocedural stroke
0-72h
Incidence of delirium after MitraClip
0-72h
Eligibility Criteria
All patients undergoing the MitraClip between April 2017 December 2019 procedure due to a severe mitral regurgitation will be enrolled in our study. All patients will be assigned to either a surgical procedure or the MitraClip-procedure by an interdisciplinary heart team according to current guidelines irrespective of this study.
You may qualify if:
- Patients undergoing a MitraClip-procedure due to mitral regurgitation in the study period Written consent Procedure recommended by a Cardio-Thoracic Surgery Conference
You may not qualify if:
- Patients who are not able to give consent Patients \<18 years Participation in another interventional Trial Pregnant or lactating females Contraindication to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite
Berlin, Germany
Related Publications (1)
Braemswig TB, Kusserow M, Bellmann B, Beckhoff F, Reinthaler M, von Rennenberg R, Erdur H, Scheitz JF, Galinovic I, Villringer K, Leistner DM, Audebert HJ, Endres M, Landmesser U, Haeusler KG, Fiebach JB, Lauten A, Rillig A, Nolte CH. New Cerebral Microbleeds After Catheter-Based Structural Heart Interventions: An Exploratory Analysis. J Am Heart Assoc. 2023 Feb 7;12(3):e8189. doi: 10.1161/JAHA.122.027284. Epub 2023 Feb 3.
PMID: 36734351DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexander Lauten, Prof. Dr.
Charite Kardiologie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. A. Lauten
Study Record Dates
First Submitted
April 1, 2017
First Posted
April 7, 2017
Study Start
April 14, 2017
Primary Completion
December 3, 2020
Study Completion
December 3, 2020
Last Updated
December 16, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share