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Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

NCT06078410 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-10-11

No results posted yet for this study

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.

Conditions

  • Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
  • Neurologic Evaluation
  • Magnetic Resonance Imaging \(MRI\)
  • Transapical Beating-Heart Septal Myectomy
  • Cardiac Surgery Involving Left Heart Operation

Interventions

PROCEDURE

Cardiac surgery

The TA-BSM group will undergo transapical beating-heart septal myectomy and the group of cardiac surgery involving left heart operation will udergo 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 & Collaborators

  • Xiang Wei

    lead OTHER

Principal Investigators

  • Xiang Wei, M.D. · Tongji Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-07-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078410 on ClinicalTrials.gov