Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

NCT06830499 | Recruiting DMC

• 1 other identifier: China Young TAVR Study
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 4

Brief Summary

Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study

Conditions

AORTIC VALVE DISEASES; Bicuspid Aortic Valve (BAV)

Keywords

TAVR; real-world; aortic valve stenosis; Sapien 3

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  The primary end point is the 5 year all-cause mortality

  At 5 years

Secondary Outcomes (21)

• The composite of all-cause mortality, stroke and rehospitalization

  At 30 days, 1, 3, 5 years

• The composite of device success

  At 30 days

• The durability performance of Sapien 3

  At 1, 3, 5 years

• Annular rupture

  At 1 day of discharge

• Paravalvular leakage

  At 1 day of discharge, 30 days, 1, 3, 5 years

Study Arms (2)

300 retrospectively enrolled patients

Procedure: TAVR

Procedure: Transcatheter Aortic Valve Replacement (TAVR)

150 prospectively enrolled patients

Procedure: TAVR

Procedure: Transcatheter Aortic Valve Replacement (TAVR)

Interventions

Transcatheter Aortic Valve Replacement (TAVR) PROCEDURE

TAVR procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted. Vascular access site will be through transfemoral on the basis of pre-procedural evaluation of access site vessel. The procedure will be performed under local or general anesthesia and per clinical practice standard.

150 prospectively enrolled patients; 300 retrospectively enrolled patients

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young (50\~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population

You may qualify if:

• years of age or older but ≤70 years old at time of consent.
• Severe AS, defined as follows:
• a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%.
• Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
• Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

You may not qualify if:

• Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases).
• Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve.
• Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.
• Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.
• Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease).
• Aortic disease: a. bicuspid aortic valve with an ascending aorta diameter ≥ 45mm b. tricuspid aortic valve with an ascending aorta diameter ≥ 50mm.
• Pre-existing mechanical or bioprosthetic valve in any position.
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.
• Emergency interventional/surgical procedures within 30 days of the valve implant procedure.
• Hypertrophic cardiomyopathy with or without obstruction.
• Ventricular dysfunction with LVEF \< 30%.
• Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation.
• Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel.
• Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure.
• Renal replacement therapy at the time of screening.

Sponsors & Collaborators

• Xijing Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Fu Wai Hospital, Beijing, China: collaborator
• West China Hospital: collaborator

Study Sites (4)

Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

NOT YET RECRUITING

Shanghai Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (9)

• Ten Berg J, Sibbing D, Rocca B, Van Belle E, Chevalier B, Collet JP, Dudek D, Gilard M, Gorog DA, Grapsa J, Grove EL, Lancellotti P, Petronio AS, Rubboli A, Torracca L, Vilahur G, Witkowski A, Mehilli J. Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: a consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease. Eur Heart J. 2021 Jun 14;42(23):2265-2269. doi: 10.1093/eurheartj/ehab196.

  PMID: 33822924 BACKGROUND

• Gupta T, DeVries JT, Gilani F, Hassan A, Ross CS, Dauerman HL. Temporal Trends in Transcatheter Aortic Valve Replacement for Isolated Severe Aortic Stenosis. J Soc Cardiovasc Angiogr Interv. 2024 Apr 5;3(7):101861. doi: 10.1016/j.jscai.2024.101861. eCollection 2024 Jul. No abstract available.

  PMID: 39132009 BACKGROUND

• Sharma T, Krishnan AM, Lahoud R, Polomsky M, Dauerman HL. National Trends in TAVR and SAVR for Patients With Severe Isolated Aortic Stenosis. J Am Coll Cardiol. 2022 Nov 22;80(21):2054-2056. doi: 10.1016/j.jacc.2022.08.787. Epub 2022 Sep 16. No abstract available.

  PMID: 36122626 BACKGROUND

• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

  PMID: 30883053 BACKGROUND

• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

  PMID: 30883058 BACKGROUND

• Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.

  PMID: 28304219 BACKGROUND

• Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.

  PMID: 27040324 BACKGROUND

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 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

MeSH Terms

Conditions

Aortic Valve Disease; Bicuspid Aortic Valve Disease; Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Jian Yang, MD, PhD

  Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Yang, MD, PhD

CONTACT

+8613892828016; yangjian@fmmu.edu.cn

Meng en Zhai, PhD

CONTACT

+8617782801836; zhaimengen@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 17, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: June 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)