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

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/A

Clinical Study ID

NCT05486000
IN-ATRIAL SEPTAL-2022-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. 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;
  3. 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);
  4. 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;
  5. Cardiac Function Classification (NYHA) Grade II-IV;
  6. 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:

  1. 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;
  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 orvegetations in the heart;
  5. Anatomical abnormalities that make surgery unfinished or anatomically unsuitable forsurgery;
  6. Life expectancy < 12 months;
  7. History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonaryembolism 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 studyas required; -

Study Design

Total Participants: 120
Study Start date:
August 01, 2022
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Atrial shunt implant system

    Nantong, Jiangsu 210046
    China

    Active - Recruiting

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