Back to resultsTransapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
Primary Purpose
Hypertrophic Obstructive 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 Hypertrophic Obstructive Cardiomyopathy focused on measuring Hypertrophic Obstructive Cardiomyopathy, Septal Myectomy, Systolic Anterior Motion, Left Ventricle Outflow Tract Obstruction, Mitral Regurgitation, Transapical, Off-pump, Minimally invasive
Eligibility Criteria
Inclusion Criteria:
- Patients whose resting or provoked left ventricular outflow tract gradient > 50 mmHg, and 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.
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 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.
Sites / Locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypertrophic Obstructive Cardiomyopathy
Arm Description
Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.
Outcomes
Primary Outcome Measures
All-cause mortality
Death from any cause during the observation period.
Procedural success
Resting left ventricle outflow tract gradients < 30 mmHg, provoked left ventricle outflow tract gradients < 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.
Secondary Outcome Measures
Device success
Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, resting left ventricle outflow tract gradient less than 50 mmHg and mitral regurgitation (MR) ≤ grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation.
Septal thickness
Basal and mid septal thickness as measured by echocardiography.
Left ventricle mass
Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.
Left ventricle volume
Left ventricle end-diastolic volume as measured by echocardiography.
Cardiac diastolic function
The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') as measured by echocardiography.
Left atria volume
The left atria volume as measured by echocardiography.
Major adverse cardiovascular and cerebral events
In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
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.
Left ventricular outflow tract gradient
Left ventricular outflow tract gradient as measured by echocardiography.
Evaluation of the mitral valve
Grade of mitral regurgitation and systolic anterior motion as measured by echocardiography.
Left ventricular outflow tract diameter
Left ventricular outflow tract diameter as measured by echocardiography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05332691
Brief Title
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
Official Title
Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: Safety and Efficacy Results of a Phase I First-in-man Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (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
No
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 septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, single-center, first-in-man study.
Detailed Description
Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, we have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy
Keywords
Hypertrophic Obstructive Cardiomyopathy, Septal Myectomy, Systolic Anterior Motion, Left Ventricle Outflow Tract Obstruction, Mitral Regurgitation, Transapical, Off-pump, Minimally invasive
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
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypertrophic Obstructive Cardiomyopathy
Arm Type
Experimental
Arm Description
Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.
Intervention Type
Procedure
Intervention Name(s)
Transapical beating-heart septal myectomy
Other Intervention Name(s)
Minimally invasive transapical septal myectomy in the beating hearts
Intervention Description
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 ventricle outlet tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the muscular resection for sufficient relief of left ventricle outlet tract obstruction and mitral regurgitation, while preventing iatrogenic injuries.
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
Resting left ventricle outflow tract gradients < 30 mmHg, provoked left ventricle outflow tract gradients < 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Device success
Description
Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, resting left ventricle outflow tract gradient less than 50 mmHg and mitral regurgitation (MR) ≤ grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation.
Time Frame
1 day
Title
Septal thickness
Description
Basal and mid septal thickness as measured by echocardiography.
Time Frame
7 days and 3 months
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
Left ventricle volume
Description
Left ventricle end-diastolic volume as measured by echocardiography.
Time Frame
7 days and 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 echocardiography.
Time Frame
7 days and 3 months
Title
Left atria volume
Description
The left atria volume as measured by echocardiography.
Time Frame
7 days and 3 months
Title
Major adverse cardiovascular and cerebral events
Description
In-hospital mortality, atrioventricular block that need permanent pacemaker implantation, sternotomy conversion, iatrogenic ventricular septal perforation, iatrogenic valvular injury, imaging examination-validated cerebral complications.
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
7 days and 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
7 days and 3 months
Title
Left ventricular outflow tract gradient
Description
Left ventricular outflow tract gradient as measured by echocardiography.
Time Frame
7 days and 3 months
Title
Evaluation of the mitral valve
Description
Grade of mitral regurgitation and systolic anterior motion as measured by echocardiography.
Time Frame
7 days and 3 months
Title
Left ventricular outflow tract diameter
Description
Left ventricular outflow tract diameter as measured by echocardiography.
Time Frame
7 days and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients whose resting or provoked left ventricular outflow tract gradient > 50 mmHg, and 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.
Exclusion Criteria:
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.
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
Links:
URL
http://academic.oup.com/icvts/article/30/2/303/5603540
Description
Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine
Learn more about this trial
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
We'll reach out to this number within 24 hrs