Severe Aortic Valve Stenosis
Conditions
Keywords
Severe Aortic Valve Stenosis, TAVR, emergency
Brief summary
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. It is a prospective, multi-center clinical study, and 35 cases are planned to be enrolled and followed up for 12 months (before discharge, 30 days, 6 months and 12 months). The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function.
Detailed description
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. The prognosis of patients with severe aortic stenosis (AS) is extremely poor in emergency, and the mortality of traditional balloon angioplasty (PBAV) is high. As a new treatment method, emergency TAVR needs multi-center data to verify its safety and effectiveness. Based on the preliminary results of a single center, this study was extended to multiple centers in China, aiming at providing high-level evidence, helping to optimize the implementation strategy of emergency TAVR, and promoting its wide application in patients with severe aortic stenosis, thus improving the clinical prognosis and quality of life of patients. This study is a prospective, multi-center clinical study, and 35 patients are planned to be enrolled. All participants are followed up before discharge, 30 days, 6 months and 12 months after valve implantation, and the research unit independently manages data, including data collection, collation and statistical analysis. The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function. The selection criteria are: patients with severe aortic stenosis diagnosed by medical treatment; Meet one of the emergency TAVR indications (shock, persistent ventricular tachycardia or ventricular fibrillation, unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance devices, etc.); Voluntary participation and signing of informed consent. The main exclusion criteria are: aortic root anatomy and lesions are not suitable for artificial valve implantation; Anatomical morphology or vascular diseases that affect the instrument approach; Left ventricular outflow tract obstruction; Primary dilated cardiomyopathy; Thrombosis in left ventricle; Patients who cannot receive anticoagulant or antiplatelet therapy, etc. The statistical methods used are descriptive analysis, Kaplan-Meier survival analysis and Cox proportional hazard model (SAS 9.4). Following the Helsinki Declaration, China's Quality Management Standard for Clinical Trials of Medical Devices and ISO 14155:2011, all patients signed informed consent forms with the approval of the Ethics Committee.
Interventions
DEVICETranscatheter aortic valve and recyclable delivery system
In this study, the transcatheter aortic valve and its recycling delivery system were VitaFlow Liberty®, a TAVR product independently developed by Shanghai Minimally Invasive Cardiovascular Treatment Co., Ltd. (approved and marketed by NMPA). This product is equipment/consumables routinely purchased by hospitals. For routine clinical use, it is designed for transcatheter aortic valve implantation. The valve is delivered to the intended implantation site via the peripheral artery by retrograde flow through the delivery system, realizing the delivery, positioning and release of the valve. Under the supervision of medical imaging equipment, the valve is delivered to the lesion site of the aortic valve, and marked by the diseased aortic annulus, to release the valve and relieve the stenosis at the lesion site, thereby ensuring smooth aortic flow, improving cardiac function and achieving therapeutic purposes.
Sponsors
Qilu Hospital of Shandong University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with severe aortic stenosis diagnosed at the clinic: peak transvalvular flow velocity ≥4.0m/s, or mean transvalvular pressure difference ≥40mmHg(1 mmHg=0.133kPa), or aortic valve orifice area \< \<0.8cm2 (or effective aortic valve orifice area index \< 0.5 cm2/m2); 2. Meet one of the following emergent TAVR indications: 1\) Shock; 2) Combined with persistent ventricular tachycardia or ventricular fibrillation; 3) Difficulty in improving unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance with drugs; 4) Cardiopulmonary resuscitation is required for cardiac arrest; 3. Patients who can understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to accept the relevant examinations and clinical follow-up.
Exclusion criteria
1. Aortic root anatomy and lesions are not suitable for prosthetic valve implantation; 2. Anatomic morphology or vascular diseases affecting the instrument approach; 3. Left ventricular outflow tract obstruction; 4. Primary dilated cardiomyopathy; 5. Thrombus in the left ventricle; 6. Patients who are unable to receive anticoagulation or antiplatelet therapy; 7. Allergy to or resistance to Nitinol; 8. Active stage of infective endocarditis or other infection that the researcher believes affects the operation; 9. Severe disability senile dementia; 10. Patients with a life expectancy of less than half a year; 11. The investigator determined that the patient or family had poor compliance or declined to complete the study as required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative all-cause mortality at 12 months postoperatively | 12 months | All-cause death includes cardiac death and non-cardiac death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury | Perioperative/Periprocedural, 30 days, 6 months, 12 months | Incidence of acute kidney injury (AKIN Grade 2 or 3, or renal replacement therapy (RRT: hemodialysis, intraperitoneal dialysis, hemofiltration)) calculated as: Occurred/Total |
| Incidence of permanent pacemaker implantation | Perioperative/Periprocedural, 30 days, 6 months, 12 months | Incidence of permanent pacemaker implantation, calculated as: Cases Occurred/Total Cases |
| Incidence of severe vascular complications | Perioperative/Periprocedural, 30 days, 6 months, 12 months | Incidence of severe vascular complications, calculated as: number of cases/total number of cases |
| The incidence of other TAVR-related complications | Perioperative/Periprocedural, 30 days, 6 months, 12 months | The incidence of other TAVR-related complications, including conversion to surgical thoracotomy, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, cardiac tamponade, endocarditis, valve thrombosis, valvular ectopic (shift, embolism, false release), valvular implant, reoperation due to valve dysfunction (TAVR, SAVR, BAV), was calculated as: Cases Occurred/Total Cases |
| Incidence of major adverse cardiovascular events | Perioperative/Periprocedural, 30 days, 6 months, 12 months | Incidence of major adverse cardiovascular events (MACCE including mortality, disabling stroke, myocardial infarction, reoperation) calculated as number of occurrences/total number of occurrences |
| Change in cardiac function (NYHA) | Perioperative/Periprocedural, 30 days, 6 months, 12 months | NYHA classification: Divided into four levels, Grade I: No discomfort in daily activities, and no restriction in physical activities. Grade II: Mild activity restriction, no symptoms at rest, but daily activities (such as climbing stairs) can cause fatigue and palpitation. Grade III: obvious activity limitation, no symptoms at rest, but slight activity (such as walking) will cause symptoms. Grade Ⅳ: There are symptoms at rest, and any activity aggravates discomfort. |
| Change in cardiac function (NT-proBNP) | Perioperative/Periprocedural, 30 days, 6 months, 12 months | NT-proBNP: Secreted by ventricular myocytes when the pressure load of the heart increases (such as heart failure and myocardial stretching), it is the precursor of BNP, obtained by laboratory examination |
| Success rate of devices, calculation method: number of successful devices/total number of cases | Perioperative/Periprocedural | calculation method: number of successful devices/total number of cases |
| Implantation of mechanical circulation assistance device (MCS) | Perioperative/Periprocedural | Implantation of mechanical circulation assistance device (MCS), calculated as: Cases of mechanical circulation assistance device implantation/Total cases |
| Valve function (assessed by echocardiography) | Perioperative/Periprocedural, 30 days, 6 months, 12 months | Valve function (assessed by echocardiography): valve function (e.g., aortic valve orifice area, mean pressure differential across the aortic valve), valve regurgitation, perivalvular leakage, moderate or severe valve stenosis |
Countries
China
Contacts
Primary ContactChuanbao Li
Outcome results
None listed