Last updated: August 1, 2022
Sponsor: Morningside (Nantong) Medical Co.,Ltd
Overall Status: Active - Recruiting
Phase
N/A
Condition
Chest Pain
Congestive Heart Failure
Hyponatremia
Treatment
N/AClinical Study ID
NCT05486000
IN-ATRIAL SEPTAL-2022-01
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years;
- Consistently stable GDMT (Guidelines for Guiding Drugs) according to The ChineseGuidelines for the Diagnosis and Treatment of Heart Failure 2018 Treatment) heartfailure for patients with chronic left heart failure who are still symptomatic for atleast 1 month;
- History of hospital admission to heart failure in the past 12 months, serum BNP orNT-proBNP liters" within 6 months High (BNP in sinus rhythm patients> 70 pg/ml, atrialfibrillation patients > 200 pg/ml, or sinus rhythm patients NT-proBNP"> 200 pg/ml,patients with atrial fibrillation >600 pg/ml);
- Cardiac catheterization measures resting mean lung capillary wedge pressure PCWP orleft atrial pressure LAP≥15 mmHg,And the difference between the RAP order of pulmonarycapillary wedge pressure PCWP and right atrial pressure is ≥ 5 mmHg;
- Cardiac Function Classification (NYHA) Grade II-IV;
- The patient or his/her guardian can understand the purpose of the study, voluntarilyparticipate and sign a written informed consent form, which is acceptable Patientsfollowed up; -
Exclusion
Exclusion Criteria:
- Primary organic valvular disease and severe coronary artery disease requiringrevascularization that are currently indicated for surgical intervention Changes,heart-related diseases indicated for pacemaker implantation treatment;
- 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 orvegetations in the heart;
- Anatomical abnormalities that make surgery unfinished or anatomically unsuitable forsurgery;
- Life expectancy < 12 months;
- History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonaryembolism in the past 6 months;
- Pregnant or lactating women, or persons with family planning in the next year;
- Subjects whose judgement of poor compliance and who were unable to complete the studyas required; -
Study Design
Total Participants: 120
Study Start date:
August 01, 2022
Estimated Completion Date:
October 31, 2026
Study Description
Connect with a study center
Atrial shunt implant system
Nantong, Jiangsu 210046
ChinaActive - Recruiting
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