To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure

NCT ID: NCT05486000

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2026-10-31

Brief 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.

Detailed Description

This trial will be carried out in a number of clinical trial institutions in China, and a total of 120 subjects are planned to be included, and all subjects are in progress The single group was registered and surgically treated with an atrial shunt implant system and within 7 days of surgery or at the time of discharge, 30 days after surgery Clinical follow-up was carried out at 3 months after surgery, 6 months after surgery, and 12 months after surgery, followed by data collection, evaluation and statistics Analysis and 12 months of phased clinical summary submitted registration application, on this basis, complete 2 years, 3 years of long-term follow-up.

Conditions

Left Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

This group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system

Group Type: EXPERIMENTAL

Atrial shunt implant system

Intervention Type: DEVICE

Patients with chronic left heart failure who meet the conditions of the clinical trial undergo interventional surgery with the "Atrial Shunt Implant System"

Interventions

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"

Intervention Type: DEVICE

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; -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiamen Cardiovascular Hospital, Xiamen University

OTHER

Sponsor Role: collaborator

Morningside (Nantong) Medical Co.,Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yan wang, dean

Role: PRINCIPAL_INVESTIGATOR

Xiamen Cardiovascular Hospital, Xiamen University

Locations

Atrial shunt implant system

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

yuchen liang, president

Role: CONTACT

ycliang@siriusmed.cn

+8613774401524

Facility Contacts

Yuchen liang

Role: primary

ycliang@siriusmed.cn

+8613774401524

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Related Links

http://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Acute-and-Chronic-Heart-Failure

Guidelines for the diagnosis and treatment of heart failure

Other Identifiers

IN-ATRIAL SEPTAL-2022-01

Identifier Type: -

Identifier Source: org_study_id