A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd. for the Treatment of Chronic Heart Failure with Elevated Left Atrial Pressure.
This is a prospective, multi-center and objective performance criteria study to evaluate the effectiveness and safety of the NoYA™ Radiofrequency Interatrial Shunt System for the treatment of chronic heart failure with elevated left atrial pressure. Patients with chronic heart failure with elevated left atrial pressure who meet study eligibility criteria will be enrolled and undergo radiofrequency ablation of the interatrial procedure with NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech) after signing the informed consent. The follow-up will be conducted at discharge, 1 month, 3 months, 6 months, and 12 months after the operation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.
Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
1. Death: Cardiac death 2. Hospitalization:HF-related Hospitalizations
Time frame: 12 months after the procedure
Acute device success
Acute device success is defined as the successful delivery and retraction of the device without immediate postoperative device-related technical failures or complications.
Time frame: Immediately post-procedure
Acute procedural success
Acute procedural success is defined as no operative death immediately after the operation, successful delivery and fully retraction of the device, no need for any emergency surgery or secondary intervention (including device-related or operative approach-related), and the presence of the left-to-right atrial blood shunt (means the shunt is patent).
Time frame: Immediately post-procedure
Change in 6-Minute Walk Test
The change of 6-minute walk test distance between baseline, 6 months, and 12 months follow-up.
Time frame: Baseline, 6 months, 12 months after procedure
Change in Nt-pro BNP
Change in Nt-pro BNP between preoperative, 1 month, 3 months, 6 months, and 12 months follow-up.
Time frame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
Change in PCWP or Mean Left Atrial Pressure
Change in resting end-expiratory PCWP (pulmonary capillary wedge pressure) or mean left atrial pressure before and immediately after the procedure.
Time frame: Before, immediately after procedure
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
RECRUITINGBeijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGXuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGXiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
RECRUITINGZhuhai People's Hospital
Zhuhai, Guangdong, China
RECRUITING...and 21 more locations
Left-to-right Atrial Blood Shunt Evaluation
Echocardiographic assessment of left-to-right atrial blood shunt at 6 months and 12 months postoperatively: peak shunt flow rate, maximum shunt orifice diameter.
Time frame: 6 months, 12 months after procedure
Change in NYHA Class
Preoperative, 1 month, 3 months, 6 months, and 12 months postoperative cardiac function class (NYHA class).
Time frame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
Change in Minnesota Living with Heart Failure Questionnaire
Preoperative, 1 month, 3months, 6 months, and 12 months postoperative Quality of life assessment in Minnesota Living with Heart Failure Questionnaire.
Time frame: Preoperative, 1 month, 3 months, 6 months, 12 months after procedure
Rate of re-admission, re-operation/intervention for heart failure
The overall incidence of re-admission, re-operation/intervention for heart failure within 1 year.
Time frame: 12 months after procedure