Transapical Beating-Heart Septal Myectomy in Patients With Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
Minimally Invasive Transapical Beating-Heart Septal Myectomy in Patients With Nonobstructive Hypertrophic Cardiomyopathy
1 other identifier
interventional
100
1 country
1
Brief Summary
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJuly 19, 2023
July 1, 2023
2 years
July 11, 2023
July 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All-cause mortality
Death from any cause during the observation period.
3 months
Procedural success
A reduction of ≥1 New York Heart Association (NYHA) class and a decrease of ≥ 20% of left atrial volume
3 months
Secondary Outcomes (11)
Device success
1 day
Septal thickness
7 days and 3 months
Left ventricle mass
7 days and 3 months
Left atrial volume
7 days and 3 months
Major adverse cardiovascular and cerebral events
3 months
- +6 more secondary outcomes
Study Arms (1)
Nonbstructive Hypertrophic Cardiomyopathy
EXPERIMENTALTransapical beating-heart septal myectomy for the patient with nonobstructive hypertrophic cardiomyopathy and Heart Failure.
Interventions
We have invented a beating-heart myectomy device.Through a minimally invasive intercostal incision, septal myectomy could be accomplished via a transapical access in the beating heart using the device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricular end-diastolic volume and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the muscular resection for sufficient enlargement of left ventricular end-diastolic volume and improvement of mitral regurgitation, while preventing iatrogenic injuries.
Eligibility Criteria
You may qualify if:
- Patients whose maximal ventricular septal wall thickness ≥ 15 mm.
- Patients with heart function of New York Heart Association ≥ class II.
- Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
- Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form
You may not qualify if:
- Patients who were pregnant.
- Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
- Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
- Patients whose estimated life expectancy \< 12 m.
- Patient who were non-compliant.
- Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiang Weilead
Study Sites (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
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: 31642911BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor and Director
Study Record Dates
First Submitted
July 11, 2023
First Posted
July 19, 2023
Study Start
July 1, 2023
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
July 19, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After the current study is published.
- Access Criteria
- All readers who were interested in the current study.
All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study.