Atrial shunt implantation for chronic left heart failure treatment

Evaluating the Safety and Efficacy of Atrial Shunt Implantation Systems for the Treatment of Patients With Chronic Left Heart Failure Prospective, Multicenter, Single-group Target Value Clinical Trials

This study is testing a new device that helps improve heart function in people with chronic left heart failure to see if it makes them feel better over time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Morningside (Nantong) Medical Co.,Ltd (other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT05486000 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of an atrial shunt implant system in patients suffering from chronic left heart failure. It is a prospective, multicenter, single-group trial that plans to recruit 120 subjects across various clinical institutions in China. Participants will undergo the implantation procedure and will be followed up at multiple intervals post-surgery to assess outcomes. The study will collect and analyze data over a period of up to three years to determine the long-term effects of the intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic chronic left heart failure who have been stable on guideline-directed medical therapy.

Not a fit: Patients with mild heart failure symptoms or those who do not meet the specific clinical criteria outlined in the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and clinical outcomes for patients with chronic left heart failure.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel intervention in the field.

Eligibility criteria

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; -

Where this trial is running

Nantong, Jiangsu

• Atrial shunt implant system — Nantong, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: yan wang, dean — Xiamen Cardiovascular Hospital, Xiamen University
• Study coordinator: yuchen liang, president

Conditions: Left Heart Failure