NCT02803294

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
14mo left

Started Jun 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2016Jul 2027

Study Start

First participant enrolled

June 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

10.1 years

First QC Date

June 7, 2016

Last Update Submit

July 14, 2021

Conditions

Symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Death from any cause

    1 year

Secondary Outcomes (13)

  • stroke

    30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  • death from cardiac causes

    30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  • myocardial infarction

    30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  • repeated hospitalization

    30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years

  • acute kidney injury

    30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  • +8 more secondary outcomes

Study Arms (1)

Aortic Stenosis/regurgitation

EXPERIMENTAL

Transcatheter aortic valve replacement

Procedure: transcatheter aortic valve replacement

Interventions

transcatheter aortic valve replacementPROCEDURE
Aortic Stenosis/regurgitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic aortic stenosis/regurgitation
  • Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  • The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
  • Patients are technical and anatomical eligible for interventions

You may not qualify if:

  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
  • Subject refuses a blood transfusion.
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
  • Life expectancy is less than one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital, School of Medicine at Zhejiang University

Hanzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (4)

  • Fan J, Chen J, Zhu G, Xu Y, Ng S, Dai H, Zhou D, Yidilisi A, Qi X, Liu X, Wang J. Impact of repositioning on brain injury following transcatheter aortic valve replacement with a self-expanding valve. Sci Rep. 2024 Jul 30;14(1):17554. doi: 10.1038/s41598-024-67748-6.

    PMID: 39080364DERIVED

  • Zhou Q, Wen J, Zhu Q, Fan J, Guan X, Chen X, He Y, Guo Y, Jiang J, Ding X, Pu Z, Huang Z, Li C, Zhang M, Liu X, Xu X, Wang J. Long-term prosthetic-associated subclinical thrombotic events evaluation by cardiac CTA after transcatheter aortic valve implantation: incidence and outcomes. Insights Imaging. 2024 May 30;15(1):125. doi: 10.1186/s13244-024-01681-0.

    PMID: 38816554DERIVED

  • Hu P, Chen H, Wang LH, Jiang JB, Li JM, Tang MY, Guo YC, Zhu QF, Pu ZX, Lin XP, Ng S, Liu XB, Wang JA. Elevated N-terminal pro C-type natriuretic peptide is associated with mortality in patients undergoing transcatheter aortic valve replacement. BMC Cardiovasc Disord. 2022 Apr 12;22(1):164. doi: 10.1186/s12872-022-02615-8.

    PMID: 35413789DERIVED

  • Fan J, Fang X, Liu C, Zhu G, Hou CR, Jiang J, Lin X, Wang L, He Y, Zhu Q, Ng S, Chen Z, Hu H, Liu X, Wang J, Leon MB. Brain Injury After Transcatheter Replacement of Bicuspid Versus Tricuspid Aortic Valves. J Am Coll Cardiol. 2020 Dec 1;76(22):2579-2590. doi: 10.1016/j.jacc.2020.09.605.

    PMID: 33243378DERIVED

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Jian-an Wang, MD,PhD

    Second Affiliated Hospital of Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianbao Liu, MD

CONTACT

+86-13857173887liuxb2009@hotmail.com

Jian-an Wang, MD,PhD

CONTACT

+86-13805786328Wang_jian_an@tom.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

CN(1)