Atrial shunt implant system: Patients with chronic left heart failure who meet the conditions of the clinical trial undergo interventional surgery with the "Atrial Shunt Implant System"
Study summary
This trial is a prospective, multicenter, single-group target-value clinical trial in which patients with chronic left heart failure are planned to be recruited.
Using the atrial shunt implantation system developed and produced by Morningside (Nantong) Medical Device Co., Ltd., the atrial septum is used to implant the instruments in the atrial septum.
to verify the safety and efficacy of the atrial shunt implant system for the treatment of patients with chronic left heart failure.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age ≥ 18 years;
2. Consistently stable GDMT (Guidelines for Guiding Drugs) according to The Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018 Treatment) heart failure for patients with chronic left heart failure who are still symptomatic for at least 1 month;
3. History of hospital admission to heart failure in the past 12 months, serum BNP or NT-proBNP liters" within 6 months High (BNP in sinus rhythm patients\> 70 pg/ml, atrial fibrillation patients \> 200 pg/ml, or sinus rhythm patients NT-proBNP"\> 200 pg/ml, patients with atrial fibrillation \>600 pg/ml);
4. Cardiac catheterization measures resting mean lung capillary wedge pressure PCWP or left atrial pressure LAP≥15 mmHg,And the difference between the RAP order of pulmonary capillary wedge pressure PCWP and right atrial pressure is ≥ 5 mmHg;
5. Cardiac Function Classification (NYHA) Grade II-IV;
6. The patient or his/her guardian can understand the purpose of the study, voluntarily participate and sign a written informed consent form, which is acceptable Patients followed up; -
Exclusion Criteria:
1. Primary organic valvular disease and severe coronary artery disease requiring revascularization that are currently indicated for surgical intervention Changes, heart-related diseases indicated for pacemaker implantation treatment;
2. Pulmonary hypertension (pulmonary vascular resistance PVR\>4WoodsUnits);
3. History of myocardial infarction or heart treatment surgery within three months;
4. Patients with infective endocarditis or ultrasound findings of thrombosis or vegetations in the heart;
5. Anatomical abnormalities that make surgery unfinished or anatomically unsuitable for surgery;
6. Life expectancy \< 12 months;
7. History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonary embolism in the past 6 months;
8. Pregnant or lactating women, or persons with family planning in the next year;
9. Subjects whose judgement of poor compliance and who were unable to complete the study as required; -
Primary outcome measure(s)
The clinical treatment success rate was 12 months after operation — Twelve months after surgery Death and heart failure-related rehospitalization were avoided 12 months after surgery
Trial sites (1)
Facility
City
Region
Status
Atrial shunt implant system
Nantong
Jiangsu
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.