Nonobstructive Hypertrophic Cardiomyopathy
Conditions
Keywords
Septal Myectomy, Transapical Beating-heart Septal Myectomy, Minimally Invasive, Midventricular obstruction and cavity obliteration, Nonobstructive Hypertrophic Cardiomyopathy
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.
Interventions
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 nonobstructive hypertrophic cardiomyopathy.
Sponsors
Xiang Wei
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Beating-Heart Myectomy Device
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm. 2. Patients with heart function of New York Heart Association ≥ class II. 3. Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies; 4. Kansas City Cardiomyopathy Questionnaire (KCCQ) score \< 80; 5. Presenting with one of the following conditions: midventricular obstruction with gradient ≥ 50 mmHg; grade II or higher diastolic dysfunction; apical aneurysm; ventricular tachycardia that needed an ICD implantation; pulmonary hypertension. 6. 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
1. Patients who were pregnant. 2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery. 3. Patients who had severe heart failure with left ventricle ejection fraction \< 50%. 4. Patients whose estimated life expectancy \< 12 months. 5. Patient who were non-compliant. 6. peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted. 7. LVOT obstruction. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 6 months | Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement of ≥10 points, New York Heart Association (NYHA) improvement ≥ 1 grade, stroke volume increased by ≥10 mL, and diastolic function grading at normal or grade I (of III) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular end-systolic volume | 7 days and 6 months | Left ventricular end-systolic volume and indexed by body surface area. A higher left ventricular end-systolic volume indicates enlarged left ventricular chamber. |
| Left ventricular end-diastolic volume | 7 days and 6 months | Left ventricular end-diastolic volume and indexed by body surface area. A higher left ventricular end-diastolic volume indicates enlarged left ventricular chamber. |
| Obliteration | 6 months | Rate of obliteration and ratio of obliteration to cavity as measured by TTE |
| Peak oxygen consumption | 6 months | Peak oxygen consumption as measured by cardiopulmonary exercise testing. |
| pVO2 | 6 months | pVO2 as measured by cardiopulmonary exercise testing. |
| Pulmonary artery wedge pressure | 3 days | Pulmonary artery wedge pressure as measured by Swan-Ganz catheter. |
| Stroke volume | 3 days | Stroke volume as measured by Swan-Ganz catheter. |
| Left ventricle mass | 6 months | Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance. |
| Cardiac diastolic function | 6 months | The ratio between early mitral inflow velocity and mitral annular early diastolic velocity ( E/e') and ratio between early mitral inflow velocity and late mitral inflow velocity (E/A) as measured by transthoracic echocardiography. |
| Left atria volume | 6 months | The left atria volume as measured by echocardiography. |
| Ventricular wall thickness | 6 months | Ventricular wall thickness as measured by echocardiography. |
| Left ventricular end-diastolic pressure | 1 day | Left ventricular end-diastolic pressure measure by hemodynamic catheterization. |
| Midventricular gradient | 1 week, 6 months | Resting and provoked midventricular gradient as measured by echocardiography. |
| Device success | 6 months | 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 | 6 months | 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 months | 6-minute walking test. A longer distance means better heart function. |
| Heart function-associated quality of life | 6 months | Score of the Kansas City Cardiomyopathy Questionnaire. A higher score means better heart function. |
| Angina level | 6 months | Score of the Seattle angina questionnaire. |
| NT-proBNP | N-terminal pro-brain natriuretic peptide | — |
| cTnI | 1 week, 6 months | cardiac troponin I |
| Major adverse cardiovascular and cerebral events | 6 months | Procedure-related mortality and unplanned surgical procedures during hospitalization, permanent pacemaker implantation, iatrogenic valvular injury, imaging examination-validated cerebral complications. |
| All cause mortality | 6 months | — |
| LVOT gradient | 1 week, 6 months | Resting and provoked left ventricular outflow tract gradient as measured by echocardiography. |
Countries
China
Outcome results
None listed