Symptomatic heart failure due to ischemic cardiomyopathy with left ventricular aneurysm
Conditions
Interventions
Intervention Group:Transcatheter Left Ventricular Restoration Clip System
Sponsors
Xiamen Cardiovascular Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Presence of a left ventricular aneurysm or scar, defined as a region of continuously akinetic myocardium (including hypokinesia, akinesia, or dyskinesia). 3. Evidence on CT or CMR indicating the aneurysm or scar is located in the ventricular septum, apex, and/or anterior wall, and surgical management is recommended. 4.Transmurality of the scar > 50% on imaging. 5.Echocardiographic or imaging evidence of viable myocardium remote from the target scar area. 6.Left ventricular ejection fraction (LVEF) > 15% and = 60 ml/m². 8.NYHA functional class II–IV. 9.Persistent heart failure symptoms despite stable guideline-directed medical therapy (GDMT) for at least 30 days. 10.Ability to perform the 6-minute walk test and complete the Kansas City Cardiomyopathy Questionnaire (KCCQ). 11.Deemed eligible for surgical intervention based on heart team evaluation. 12.Life expectancy > 12 months and willingness to comply with study follow-up schedule. 13.Subject has been informed of the nature of the study, understands the purpose of the clinical research, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of masses, thrombi, or vegetations in the left atrium or ventricle on echocardiography. 2. Calcification in the target scar region as indicated by imaging. 3. Pulmonary artery systolic pressure > 60 mmHg as measured by echocardiography or right heart catheterization, and/or evidence of other pulmonary heart diseases. 4. Severe right ventricular dysfunction. 5. Cardiac pacing, cardiac resynchronization therapy (CRT-P or CRT-D), or implantable cardioverter defibrillator (ICD) within 60 days; or indication for CRT-P/CRT-D without implantation. 6. Other severe structural heart diseases requiring surgical intervention. 7.Moderate or severe functional or primary mitral regurgitation. 8. Acute myocardial infarction within 90 days; or untreated severe coronary artery stenosis/disease; or revascularization deemed necessary by the investigator. 9. Hemodynamically significant ventricular arrhythmias. 10. Stroke, transient ischemic attack (TIA), any intracranial hemorrhage, permanent neurological deficits, or known intracranial pathology within the past 6 months. 11. Contraindications to cardiac CT, MRI, or left/right ventriculography. 12. Contraindications to general anesthesia. 13.Bleeding or coagulation disorders, or contraindications to antithrombotic therapy. 14. Known allergy or contraindication to device materials. 15. Active infective endocarditis. 16. Hemodynamic instability, defined as systolic blood pressure 2.5 mg/dL and/or estimated GFR < 30 ml/min). 24. Life expectancy <=1 year, or comorbidities that may confound assessment (e.g., active malignancy in clinical remission, severe metabolic disorders, psychiatric illness). 25. Pregnant, planning to become pregnant, or currently breastfeeding. 26. Participation in another investigational drug or device trial that has not yet reached its primary endpoint or may interfere with the endpoints of this study (continued follow-up of completed pre-market studies is not considered investigational). 27.Poor compliance or inability to complete the study protocol as determined by the investigator; or other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular End Systolic Volume Index,LVESVI;Major adverse events; | — |
Countries
China
Contacts
Public ContactYan Wang
Xiamen Cardiovascular Hospital of Xiamen University
Outcome results
None listed