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

August 1, 2022 updated by: Morningside (Nantong) Medical Co.,Ltd

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 210046
        • Recruiting
        • Atrial shunt implant system
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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; -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
This group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system
Device: 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinical treatment success rate was 12 months after operation
Time Frame: Twelve months after surgery
Death and heart failure-related rehospitalization were avoided 12 months after surgery
Twelve months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrument success rate
Time Frame: Intraoperative
The diverter was successfully implanted, the morphology was normal, and the conveyor system was successfully withdrawn
Intraoperative
Surgical success rate
Time Frame: Immediately after surgery
On the basis of the success of the instrument, ultrasound is seen in simple left-to-right shunting immediately after surgery
Immediately after surgery
6 minutes walking distance change
Time Frame: Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery 30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery
The participants were assessed at the appropriate follow-up site
Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery 30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery
New York Cardiac Function Grading NYHA
Time Frame: Preoperative screening ，30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery
New York Cardiac Function Grading NYHA is divided into four levels, which are determined according to the clinical presentation of the patient, and the higher the level, the more severe the symptoms of heart failure
Preoperative screening ，30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery
Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes
Time Frame: Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery
Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes consisted of a total of 23 items with a score between 0-100, with higher scores indicating less adverse effects of heart failure on a patient's quality of life
Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery
NT-proBNP or BNP variation
Time Frame: Preoperative screening ，Before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Corresponding follow-up sites are obtained by laboratory blood tests
Preoperative screening ，Before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Probability of postoperative echocardiographic changes
Time Frame: During surgery, before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Obtained through instrumentation inspection
During surgery, before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Incidence of device-related serious adverse events
Time Frame: 30 days after surgery
Serious adverse events related to the instrument that occur after the implantation of the instrument, such as the shedding of the instrument, embolism, causing damage to the mitral or tricuspid valve, causing severe arrhythmias, infectious endocarditis, any need to re-operate the instrument to remove the instrument, etc
30 days after surgery
Serious adverse events and incidence of adverse events
Time Frame: Intraoperative complications, 30 days before discharge, 3 months, 6 months, 1 year, 2 years, 3 years
Events that occur during clinical trials that result in death or serious deterioration of health status, as well as the probability of adverse medical events that occur after a subject is treated with a trial product
Intraoperative complications, 30 days before discharge, 3 months, 6 months, 1 year, 2 years, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morningside (Nantong) Medical Co.,Ltd

Collaborators

Xiamen Cardiovascular Hospital, Xiamen University

Investigators

  • Principal Investigator: yan wang, dean, Xiamen Cardiovascular Hospital, Xiamen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

October 1, 2026

Study Completion (Anticipated)

October 1, 2026

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-ATRIAL SEPTAL-2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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