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Tests treatment safety and results for Left Heart Failure
Official title To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure
ClinicalTrials.gov ID: NCT05486000
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years;
- Consistently stable GDMT (Guidelines for Guiding Drugs) according to The Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018...
- 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...
- Cardiac catheterization measures resting mean lung capillary wedge pressure PCWP or left atrial pressure LAP≥15 mmHg,And the difference between the...
- Cardiac Function Classification (NYHA) Grade II-IV;
You likely can't join if
- Primary organic valvular disease and severe coronary artery disease requiring revascularization that are currently indicated for surgical...
- Pulmonary hypertension (pulmonary vascular resistance PVR\>4WoodsUnits);
- History of myocardial infarction or heart treatment surgery within three months;
- Patients with infective endocarditis or ultrasound findings of thrombosis or vegetations in the heart;
- Anatomical abnormalities that make surgery unfinished or anatomically unsuitable for surgery;
- Life expectancy \< 12 months;
See the full eligibility criteria
- Age ≥ 18 years;
- 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...
- 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...
- 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...
- Cardiac Function Classification (NYHA) Grade II-IV;
- 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； -
- 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...
- Pulmonary hypertension (pulmonary vascular resistance PVR\>4WoodsUnits);
- History of myocardial infarction or heart treatment surgery within three months;
- Patients with infective endocarditis or ultrasound findings of thrombosis or vegetations in the heart;
- Anatomical abnormalities that make surgery unfinished or anatomically unsuitable for surgery;
- Life expectancy \< 12 months;
- History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonary embolism in the past 6 months;
- Pregnant or lactating women, or persons with family planning in the next year;
- people whose judgement of poor compliance and who were unable to complete the study as required; -
The study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.