Adult patients with heart failure who have sinus rhythm or atrial fibrillation, a left ventricular ejection fraction (LVEF) of 25% <= LVEF <= 45%, and a persistent NYHA Class ? to ? despite optimal medical therapy (refractory to medical treatment)
Conditions
Interventions
Single arm:The management of heart failure utilizing an implantable system for regulating systolic force
Sponsors
Hefei Gaoxin Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged between 18 and 80 years old (including 18 and 80 years old), regardless of gender; 2. with heart failure of NYHA Class ? to ? persistently, despite receiving guideline-directed medical therapy (GDMT) for at least 90 days; 3. 25% <= LVEF <= 45%; 4. QRS duration < 130ms; 5. Good compliance, voluntary participation and signing of the subject informed consent, and regular follow-up.
Exclusion criteria
Exclusion criteria: 1. Have been implanted with CRT or have CRT indications; 2. Subjects with potentially correctable causes of heart failure, such as valvular heart disease or congenital heart disease; 3. patients with tricuspid valve replacement; 4. Subjects with clinically significant angina, including angina in daily life (i.e., Canadian Cardiovascular Society (CCS) angina rating II or higher); 5. Participants who received intravenous injection of positive inotropic drugs (except levosimendan) within 30 days before enrollment; 6. Exercise tolerance is limited by illness other than heart failure or inability to participate in the 6-minute walk; 7. Subjects who have received a heart transplant; 8. Patients who do not have access to vascular access to implant leads; 9. Patients who are not considered suitable to participate in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in left ventricular ejection fraction (LVEF) at 6 months after surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart function grade of NYHA;MLHFQ rating;Left Ventricular End-systolic Volume;6MWT, 6 minute walking test;NT-proBNP;LVEF, left ventricular ejection fraction;Mortality from all causes and rates of readmission for heart failure; | — |
Countries
China
Contacts
Public ContactKejiang Cao
Hefei Gaoxin Cardiovascular Hospital
Outcome results
None listed