A Prospective Cohort Study of Neurologic Evaluation in Patients Recevied Transapical Beating-heart Septal Myectomy or General Cardiac Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

The goal of this prospective cohort study is to evaluate the neurologic changes in patients that received transapical beating-heart septal myectomy. The main questions are: whether this novel operation way would cause neurologic impairment; whether this novel operation way have similar neurologic lesions, compared to other cardiac surgery ways. Participants will undergo detailed neurologic and cognitive assessment at baseline, after procedure, and at 30 days. Researchers will compare the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e. Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) to assess the safety of transapical beating-heart septal myectomy on nervous system.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Xiang Wei, M.D.
xiangwei@tjh.tjmu.edu.cn
+8613995525956
Backup
Yue Chen, M.D.
chenyue@hust.edu.cn
+8615623410310
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 50
Treatments
TA-BSM
patients received transapical beating-heart septal myectomy
Cardiac surgery involving left heart operation
patients received cardiac surgery involving left heart operation, such as valvuloplasty, valve replacement, repair of auricular septal defect, repair of auricular/ventricular septal defect
Sponsors
Leads: Xiang Wei

This content was sourced from clinicaltrials.gov