Back to resultsTo Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure
Primary Purpose
Left Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atrial shunt implant system
Sponsored by
About this trial
This is an interventional treatment trial for Left Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years;
- 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;
- 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);
- 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；
- Cardiac Function Classification (NYHA) Grade II-IV;
- 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:
- 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;
- 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 or vegetations in the heart;
- Anatomical abnormalities that make surgery unfinished or anatomically unsuitable for surgery;
- Life expectancy < 12 months;
- History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonary embolism 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 study as required; -
Sites / Locations
- Atrial shunt implant systemRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
This group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system
Outcomes
Primary Outcome Measures
The clinical treatment success rate was 12 months after operation
Death and heart failure-related rehospitalization were avoided 12 months after surgery
Secondary Outcome Measures
Instrument success rate
The diverter was successfully implanted, the morphology was normal, and the conveyor system was successfully withdrawn
Surgical success rate
On the basis of the success of the instrument, ultrasound is seen in simple left-to-right shunting immediately after surgery
6 minutes walking distance change
The participants were assessed at the appropriate follow-up site
New York Cardiac Function Grading NYHA
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
Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes
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
NT-proBNP or BNP variation
Corresponding follow-up sites are obtained by laboratory blood tests
Probability of postoperative echocardiographic changes
Obtained through instrumentation inspection
Incidence of device-related serious adverse events
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
Serious adverse events and incidence of adverse events
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
Full Information
NCT ID
NCT05486000
First Posted
July 26, 2022
Last Updated
August 1, 2022
Sponsor
Morningside (Nantong) Medical Co.,Ltd
Collaborators
Xiamen Cardiovascular Hospital, Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT05486000
Brief Title
To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morningside (Nantong) Medical Co.,Ltd
Collaborators
Xiamen Cardiovascular Hospital, Xiamen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
This group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system
Intervention Type
Device
Intervention Name(s)
Atrial shunt implant system
Intervention Description
Patients with chronic left heart failure who meet the conditions of the clinical trial undergo interventional surgery with the "Atrial Shunt Implant System"
Primary Outcome Measure Information:
Title
The clinical treatment success rate was 12 months after operation
Description
Death and heart failure-related rehospitalization were avoided 12 months after surgery
Time Frame
Twelve months after surgery
Secondary Outcome Measure Information:
Title
Instrument success rate
Description
The diverter was successfully implanted, the morphology was normal, and the conveyor system was successfully withdrawn
Time Frame
Intraoperative
Title
Surgical success rate
Description
On the basis of the success of the instrument, ultrasound is seen in simple left-to-right shunting immediately after surgery
Time Frame
Immediately after surgery
Title
6 minutes walking distance change
Description
The participants were assessed at the appropriate follow-up site
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
Title
New York Cardiac Function Grading NYHA
Description
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
Time Frame
Preoperative screening ，30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery
Title
Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes
Description
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
Time Frame
Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery
Title
NT-proBNP or BNP variation
Description
Corresponding follow-up sites are obtained by laboratory blood tests
Time Frame
Preoperative screening ，Before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Title
Probability of postoperative echocardiographic changes
Description
Obtained through instrumentation inspection
Time Frame
During surgery, before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Title
Incidence of device-related serious adverse events
Description
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
Time Frame
30 days after surgery
Title
Serious adverse events and incidence of adverse events
Description
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
Time Frame
Intraoperative complications, 30 days before discharge, 3 months, 6 months, 1 year, 2 years, 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years;
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;
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);
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；
Cardiac Function Classification (NYHA) Grade II-IV;
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:
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;
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 or vegetations in the heart;
Anatomical abnormalities that make surgery unfinished or anatomically unsuitable for surgery;
Life expectancy < 12 months;
History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonary embolism 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 study as required; -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yuchen liang, president
Phone
+8613774401524
Email
ycliang@siriusmed.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yan wang, dean
Organizational Affiliation
Xiamen Cardiovascular Hospital, Xiamen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrial shunt implant system
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
210046
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuchen liang
Phone
+8613774401524
Email
ycliang@siriusmed.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Acute-and-Chronic-Heart-Failure
Description
Guidelines for the diagnosis and treatment of heart failure
Learn more about this trial
To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure
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