Actively Recruiting
To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure
Led by Morningside (Nantong) Medical Co.,Ltd · Updated on 2022-08-03
120
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
M
Morningside (Nantong) Medical Co.,Ltd
Lead Sponsor
X
Xiamen Cardiovascular Hospital, Xiamen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Stable guideline-directed medical therapy for chronic left heart failure with symptoms for at least 1 month
- History of hospitalization for heart failure within the past 12 months
- Elevated serum BNP or NT-proBNP levels within 6 months (BNP >70 pg/ml in sinus rhythm, >200 pg/ml in atrial fibrillation; NT-proBNP >200 pg/ml in sinus rhythm, >600 pg/ml in atrial fibrillation)
- Cardiac catheterization showing resting mean pulmonary capillary wedge pressure or left atrial pressure ≥15 mmHg and a pressure difference of ≥5 mmHg between pulmonary capillary wedge pressure and right atrial pressure
- New York Heart Association (NYHA) Functional Classification Grade II-IV
- Ability to understand the study purpose, voluntarily participate, provide informed consent, and comply with follow-up
You will not qualify if you...
- Primary organic valvular disease or severe coronary artery disease requiring surgical intervention
- Heart conditions requiring pacemaker implantation
- Pulmonary hypertension with pulmonary vascular resistance >4 Wood units
- Myocardial infarction or heart surgery within the past 3 months
- Infective endocarditis or presence of thrombosis or vegetations in the heart
- Anatomical abnormalities preventing or unsuitable for surgery
- Life expectancy less than 12 months
- History of stroke, transient cerebral ischemia, deep vein thrombosis, or pulmonary embolism within the past 6 months
- Pregnant or lactating women, or planning pregnancy within the next year
- Poor compliance or inability to complete study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Atrial shunt implant system
Nantong, Jiangsu, China, 210046
Actively Recruiting
Research Team
Y
yuchen liang, president
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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