NCT06078410

Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Xiang Wei · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Nervous system complication is one of the common complications caused by cardiac surgery, including ischemic stroke, encephalopathy, neurocognitive dysfunction, which can increase the mortality of patients, hospitalization cost and lead to long-term quality of life impairment. At present, embolism is considered to be the main mechanism of postoperative nervous system complication. Imaging studies have confirmed that 30% to 50% of perioperative strokes are caused by brain embolism larger than 200 μm. For example, a study using diffusion-weighted magnetic resonance imaging (DW-MRI) found that 66% of patients who received aortic valve replacement had a new cerebral infarction with a brain injury volume of about 126 mm3. Recently, our team have invented a novel surgical method called transapical beating-heart septal myectomy (TA-BSM) to cure hypertrophic obstructive cardiomyopathy (HOCM). To date, this novel therapy displayed ideal effectiveness on these patients, however, whether this novel operation way would cause neurologic impairment is unclear. In this study, researchers will compare TA-BSM with cardiac surgery involving left heart operation, and analyze 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) in these patients received above therapies. This study is to assess the safety of TA-BSM on nervous system and contributes the further improvement of this novel cardiac surgery.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-07-31
• Completion: 2024-12-31
• First posted: 2023-10-11
• Last updated: 2023-10-11

Locations

1 site across 1 country: China