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

NCT07108478 | Not Yet Recruiting

• 1 other identifier: KYLL-202503-007-1
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Aortic Valve Stenosis

Keywords

Severe Aortic Valve Stenosis; TAVR; emergency

Outcome Measures

Primary Outcomes (1)

• Cumulative all-cause mortality at 12 months postoperatively

  All-cause death includes cardiac death and non-cardiac death

  12 months

Secondary Outcomes (10)

• Incidence of major adverse cardiovascular events

  Perioperative/Periprocedural, 30 days, 6 months, 12 months

• Incidence of acute kidney injury

  Perioperative/Periprocedural, 30 days, 6 months, 12 months

• Incidence of permanent pacemaker implantation

  Perioperative/Periprocedural, 30 days, 6 months, 12 months

• Incidence of severe vascular complications

  Perioperative/Periprocedural, 30 days, 6 months, 12 months

• The incidence of other TAVR-related complications

  Perioperative/Periprocedural, 30 days, 6 months, 12 months

Study Arms (1)

Case

Device: Transcatheter aortic valve and recyclable delivery system

Interventions

Transcatheter aortic valve and recyclable delivery system DEVICE

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.

Case

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1\. Severe aortic stenosis 2, high risk of surgery, or surgical taboo, is not suitable for conventional surgery valve replacement; 3, anatomically suitable for TAVI/TAVR

You may qualify if:

• 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:
• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.

  PMID: 12473543 BACKGROUND

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 BACKGROUND

• Carabello BA, Paulus WJ. Aortic stenosis. Lancet. 2009 Mar 14;373(9667):956-66. doi: 10.1016/S0140-6736(09)60211-7. Epub 2009 Feb 21.

  PMID: 19232707 BACKGROUND

• Supino PG, Borer JS, Preibisz J, Bornstein A. The epidemiology of valvular heart disease: a growing public health problem. Heart Fail Clin. 2006 Oct;2(4):379-93. doi: 10.1016/j.hfc.2006.09.010. No abstract available.

  PMID: 17448426 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Emergencies

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chuanbao Li

CONTACT

+86 18560083097; bao2460@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 7, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)