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NCT Number: NCT02803294

Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

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

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Key information

Conditions

Symptomatic Aortic Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital, School of Medicine at Zhejiang University

Hanzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xianbao Liu, PHD

CONTACT

[email protected]

About this study

Subjects enrolled are those who undergo physical exams and screening tests and were classified as a patient with symptomatic aortic stenosis or severe aortic regurgitation. They are then performed transcatheter aortic valve replacement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Transcatheter aortic valve replacement

Procedure

Primary outcomes

  1. Death from any cause

    Time frame: 1 year

Secondary outcomes

  1. stroke

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

  2. death from cardiac causes

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

  3. myocardial infarction

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

  4. repeated hospitalization

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

  5. acute kidney injury

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

  6. vascular complications

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

  7. bleeding events

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

  8. device success

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

    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  9. Functional Improvement from baseline per New York Heart Association functional classification

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

  10. permanent pacemaker implantation

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

    number of patients who develop permanent third-degree or type 2(Mobitz) Secondary atrioventricular block after transcatheter aortic valve replacement and need permanent pacemaker implantation.

  11. transcatheter valve failure

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

    leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve

  12. changes in ascending aorta diameter

    Time frame: 1 year,2 years, 3 years, 4 years, 5 years，10 years

  13. Death from all causes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jian-an Wang, MD,PhD

CONTACT

[email protected]

+86-13805786328

Xianbao Liu, MD

CONTACT

[email protected]

+86-13857173887

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Acronym: TORCH

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Jun 16, 2016
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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