Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

NCT06078410 | Unknown

• 1 other identifier: 2023-S034
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The incidence of diffusion-weighted MRI lesions

  the number (n) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months

  3 months

• The volume of new brain lesions measured by diffusion-weighted MRI

  the volume (mL) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months

  3 months

Secondary Outcomes (7)

• neurologic injury

  7 days and 3 months

• all-cause and cardiovascular mortality

  7 days and 3 months

• montreal cognitive assessment

  7 days and 3 months

• national Institute of Health stroke scale

  7 days and 3 months

• modified rankin scale

  7 days and 3 months

Study Arms (2)

TA-BSM

patients received transapical beating-heart septal myectomy

Procedure: Cardiac surgery

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

Interventions

Cardiac surgery PROCEDURE

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.

TA-BSM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients suffer from hypertrophic obstructive cardiomyopathy or the other cardiovascular disease and have to receive cardiac surgery involving left heart operation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang Wei: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (1)

• Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10.1093/icvts/ivz249.

  PMID: 31642911 RESULT

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Xiang Wei, M.D.

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Xiang Wei, M.D.

CONTACT

+8613995525956; xiangwei@tjh.tjmu.edu.cn

Yue Chen, M.D.

CONTACT

+8615623410310; chenyue@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 11, 2023
• Study Start: October 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the current study is published

Locations

CN (1)