Back to resultsTransapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy
Primary Purpose
Apical Hypertrophic Cardiomyopathy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transapical beating-heart septal myectomy
Sponsored by
About this trial
This is an interventional treatment trial for Apical Hypertrophic Cardiomyopathy focused on measuring Apical Hypertrophic Cardiomyopathy, Septal Myectomy, Transapical Beating-heart Septal Myectomy, Minimally Invasive, Midventricular obstruction and cavity obliteration
Eligibility Criteria
Inclusion Criteria: Patients who were diagnosed as apical hypertrophic cardiomyopathy, with maximal apical 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. Exclusion Criteria: Patients who were pregnant. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery. Patients who had severe heart failure with left ventricle ejection fraction < 40%. Patients whose estimated life expectancy < 12 months. 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.
Sites / Locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Apical Hypertrophic Cardiomyopathy
Arm Description
Transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy
Outcomes
Primary Outcome Measures
All-cause mortality
Death from any cause during the observation period.
Procedural success
Body surface area-indexed left ventricular end-diastolic volume increased by 10% compared with baseline as measured by echocardiography. A higher left ventricular end-diastolic volume indicates enlarged left ventricular chamber.
Secondary Outcome Measures
Left ventricular end-diastolic pressure
Left ventricular end-diastolic pressure measure by hemodynamic catheterization.
Left ventricular end-systolic volume
Left ventricular end-diastolic volume as measured by echocardiography and indexed by body surface area. A higher left ventricular end-systolic volume indicates enlarged left ventricular chamber.
Peak oxygen consumption
Peak oxygen consumption as measured by cardiopulmonary exercise testing.
Pulmonary artery wedge pressure
Pulmonary artery wedge pressure as measured by Swan-Ganz catheter.
Stroke volume
Stroke volume as measured by Swan-Ganz catheter.
Left ventricle mass
Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Cardiac diastolic function
The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') as measured by transthoracic echocardiography.
Left atria volume
The left atria volume as measured by echocardiography.
Ventricular wall thickness
Ventricular wall thickness as measured by echocardiography.
Device success
Successful accession, delivery, and retrieval of the resection device, successful resection of the ventricular myocardium, and free from conversion to midline thoracotomy during operation.
New York Heart Association class
New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.
6-minute walking test
6-minute walking test. A longer distance means better heart function.
Heart function-associated quality of life
Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.
Major adverse cardiovascular and cerebral events
Procedure-related mortality and unplanned surgical procedures during hospitalization, permanent pacemaker implantation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05648825
Brief Title
Transapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy
Official Title
Transapical Beating-heart Myectomy in Patient With Apical Hypertrophic Cardiomyopathy: Safety and Efficacy Results of a Phase I Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiang Wei
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Hypertrophic Cardiomyopathy
Keywords
Apical Hypertrophic Cardiomyopathy, Septal Myectomy, Transapical Beating-heart Septal Myectomy, Minimally Invasive, Midventricular obstruction and cavity obliteration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Beating-Heart Myectomy Device
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Apical Hypertrophic Cardiomyopathy
Arm Type
Experimental
Arm Description
Transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy
Intervention Type
Device
Intervention Name(s)
Transapical beating-heart septal myectomy
Intervention Description
We have invented a beating-heart myectomy device. Using this device, myectomy could be performed in the beating heart via a mini-thoractomy approach. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. We are now conducting the study to explore the feasibility, the safety, and the efficacy of transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy.
Primary Outcome Measure Information:
Title
All-cause mortality
Description
Death from any cause during the observation period.
Time Frame
3 months
Title
Procedural success
Description
Body surface area-indexed left ventricular end-diastolic volume increased by 10% compared with baseline as measured by echocardiography. A higher left ventricular end-diastolic volume indicates enlarged left ventricular chamber.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Left ventricular end-diastolic pressure
Description
Left ventricular end-diastolic pressure measure by hemodynamic catheterization.
Time Frame
1 day
Title
Left ventricular end-systolic volume
Description
Left ventricular end-diastolic volume as measured by echocardiography and indexed by body surface area. A higher left ventricular end-systolic volume indicates enlarged left ventricular chamber.
Time Frame
7 days and 3 months
Title
Peak oxygen consumption
Description
Peak oxygen consumption as measured by cardiopulmonary exercise testing.
Time Frame
3 months
Title
Pulmonary artery wedge pressure
Description
Pulmonary artery wedge pressure as measured by Swan-Ganz catheter.
Time Frame
3 days
Title
Stroke volume
Description
Stroke volume as measured by Swan-Ganz catheter.
Time Frame
3 days
Title
Left ventricle mass
Description
Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Time Frame
3 months
Title
Cardiac diastolic function
Description
The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') as measured by transthoracic echocardiography.
Time Frame
3 months
Title
Left atria volume
Description
The left atria volume as measured by echocardiography.
Time Frame
3 months
Title
Ventricular wall thickness
Description
Ventricular wall thickness as measured by echocardiography.
Time Frame
3 months
Title
Device success
Description
Successful accession, delivery, and retrieval of the resection device, successful resection of the ventricular myocardium, and free from conversion to midline thoracotomy during operation.
Time Frame
3 months
Title
New York Heart Association class
Description
New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.
Time Frame
3 months
Title
6-minute walking test
Description
6-minute walking test. A longer distance means better heart function.
Time Frame
3 months
Title
Heart function-associated quality of life
Description
Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function.
Time Frame
3 months
Title
Major adverse cardiovascular and cerebral events
Description
Procedure-related mortality and unplanned surgical procedures during hospitalization, permanent pacemaker implantation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who were diagnosed as apical hypertrophic cardiomyopathy, with maximal apical 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.
Exclusion Criteria:
Patients who were pregnant.
Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery.
Patients who had severe heart failure with left ventricle ejection fraction < 40%.
Patients whose estimated life expectancy < 12 months.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Wei, M.D.
Phone
+8613995525956
Email
xiangwei@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Fang, M.D.
Phone
+8613296640596
Email
jingfang@hust.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Wei, M.D.
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Wei, M.D.
Phone
+8613995525956
Email
xiangwei@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jing Fang, M.D.
Phone
+8613296640596
Email
jingfang@hust.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study.
IPD Sharing Time Frame
After the current study is published.
IPD Sharing Access Criteria
All readers who were interested in the current study.
Citations:
PubMed Identifier
31642911
Citation
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.
Results Reference
background
PubMed Identifier
20176208
Citation
Schaff HV, Brown ML, Dearani JA, Abel MD, Ommen SR, Sorajja P, Tajik AJ, Nishimura RA. Apical myectomy: a new surgical technique for management of severely symptomatic patients with apical hypertrophic cardiomyopathy. J Thorac Cardiovasc Surg. 2010 Mar;139(3):634-40. doi: 10.1016/j.jtcvs.2009.07.079.
Results Reference
background
Learn more about this trial
Transapical Beating-heart Myectomy for the Treatment of Apical Hypertrophic Cardiomyopathy
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