A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis

Overview

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

• Device Transcatheter 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 flo

Primary outcome measures

• Cumulative all-cause mortality at 12 months postoperatively [Time frame: 12 months]

Secondary outcome measures (10)

• Incidence of major adverse cardiovascular events [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• Incidence of acute kidney injury [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• Incidence of permanent pacemaker implantation [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• Incidence of severe vascular complications [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• The incidence of other TAVR-related complications [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• Valve function (assessed by echocardiography) [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• Change in cardiac function (NYHA) [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• Change in cardiac function (NT-proBNP) [Time frame: Perioperative/Periprocedural, 30 days, 6 months, 12 months]
• Success rate of devices, calculation method: number of successful devices/total number of cases [Time frame: Perioperative/Periprocedural]
• Implantation of mechanical circulation assistance device (MCS) [Time frame: Perioperative/Periprocedural]

Eligibility criteria

Inclusion criteria

• 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);
• 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

• Aortic root anatomy and lesions are not suitable for prosthetic valve implantation;
• Anatomic morphology or vascular diseases affecting the instrument approach;
• Left ventricular outflow tract obstruction;
• Primary dilated cardiomyopathy;
• Thrombus in the left ventricle;
• Patients who are unable to receive anticoagulation or antiplatelet therapy;
• Allergy to or resistance to Nitinol;
• Active stage of infective endocarditis or other infection that the researcher believes affects the operation;
• Severe disability senile dementia;
• Patients with a life expectancy of less than half a year;
• The investigator determined that the patient or family had poor compliance or declined to complete the study as required.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinan

Publications

• Kodali SK, Thourani VH, Kirtane AJ. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2016 Apr 21;374(16):1591. doi: 10.1056/NEJMc1600179. No abstract available. PMID 27096593
• Pache G, Schoechlin S, Blanke P, Dorfs S, Jander N, Arepalli CD, Gick M, Buettner HJ, Leipsic J, Langer M, Neumann FJ, Ruile P. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J. 2016 Jul 21;37(28):2263-71. doi: 10.1093/eurheartj/ehv526. Epub 2015 Oct 7. PMID 26446193
• Frerker C, Schewel J, Schluter M, Schewel D, Ramadan H, Schmidt T, Thielsen T, Kreidel F, Schlingloff F, Bader R, Wohlmuth P, Schafer U, Kuck KH. Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis. EuroIntervention. 2016 Apr 20;11(13):1530-6. doi: 10.4244/EIJY15M03_03. PMID 25751886
• Huang H, Kovach CP, Bell S, Reisman M, Aldea G, McCabe JM, Dvir D, Don C. Outcomes of Emergency Transcatheter Aortic Valve Replacement. J Interv Cardiol. 2019 Nov 3;2019:7598581. doi: 10.1155/2019/7598581. eCollection 2019. PMID 31777471
• Bongiovanni D, Kuhl C, Bleiziffer S, Stecher L, Poch F, Greif M, Mehilli J, Massberg S, Frey N, Lange R, Laugwitz KL, Schymik G, Frank D, Kupatt C. Emergency treatment of decompensated aortic stenosis. Heart. 2018 Jan;104(1):23-29. doi: 10.1136/heartjnl-2016-311037. Epub 2017 May 31. PMID 28566471
• Block PC, Palacios IF. Clinical and hemodynamic follow-up after percutaneous aortic valvuloplasty in the elderly. Am J Cardiol. 1988 Oct 1;62(10 Pt 1):760-3. doi: 10.1016/0002-9149(88)91218-0. PMID 3421177
• Buchwald AB, Meyer T, Scholz K, Schorn B, Unterberg C. Efficacy of balloon valvuloplasty in patients with critical aortic stenosis and cardiogenic shock--the role of shock duration. Clin Cardiol. 2001 Mar;24(3):214-8. doi: 10.1002/clc.4960240308. PMID 11288967
• Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation. 2006 Oct 10;114(15):1616-24. doi: 10.1161/CIRCULATIONAHA.106.639450. Epub 2006 Oct 2. PMID 17015786

Identifiers

NCT: NCT07108478 · KYLL-202503-007-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗