Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

Launched by XIANG WEI · Oct 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new heart surgery called transapical beating-heart septal myectomy on the brain and nervous system of patients. The main goal is to find out if this surgery causes any neurological problems, like changes in thinking or memory, compared to other types of heart surgeries. Participants in the study will undergo thorough brain and cognitive tests before the surgery, right after, and again 30 days later to see how well their brain is functioning and to check for any brain changes using advanced imaging techniques.

To be eligible for this trial, participants should have conditions that require the transapical beating-heart septal myectomy or similar heart surgeries, like hypertrophic obstructive cardiomyopathy, and be willing to attend follow-up evaluations. However, individuals with recent severe brain issues, certain medical implants, or those unable to undergo brain scans would not qualify. If you decide to participate, you can expect careful monitoring of your neurological health throughout the study, helping researchers understand the safety of this innovative surgery for both the heart and the brain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • meets indications for transapical beating-heart septal myectomy procedure or these cardiac surgery involving left heart operation, such as hypertrophic obstructive cardiomyopathy, mitral valve prolapse, and ventricular septal defect; willing to comply with protocol-specified follow-up evaluations.
• Exclusion Criteria:
• • severe brain infarction, such stroke and cerebral hemorrhage recently; the implantation of metal materials, including Pacemaker; not able to undergo MRI examination; peptic ulcer or recent gastrointestinal bleeding (\<6 months); the history of myocardial infarction; cognitive impairment in the past; not able to finish nervous system evaluation scale.