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Trial record 6 of 425 for:    aortic valve replacement

Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population (TORCH)

This study is not yet open for participant recruitment.
Verified June 2016 by Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02803294
First Posted: June 16, 2016
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.

Condition Intervention Phase
Symptomatic Aortic Stenosis Procedure: transcatheter aortic valve replacement Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THE TORCH TRIAL:Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Resource links provided by NLM:


Further study details as provided by Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University:

Primary Outcome Measures:
  • Death from any cause [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • stroke [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ]
  • death from cardiac causes [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ]
  • myocardial infarction [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ]
  • repeated hospitalization [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years, 10 years ]
  • acute kidney injury [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ]
  • vascular complications [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ]
  • bleeding events [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ]
  • 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)

  • 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 ]
  • 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.

  • 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

  • changes in ascending aorta diameter [ Time Frame: 1 year,2 years, 3 years, 4 years, 5 years,10 years ]
  • Death from all causes [ Time Frame: 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years,10 years ]

Estimated Enrollment: 2000
Study Start Date: June 2016
Estimated Primary Completion Date: July 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aortic Stenosis/regurgitation
Transcatheter aortic valve replacement
Procedure: transcatheter aortic valve replacement

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803294


Contacts
Contact: Xianbao Liu, MD +86-13857173887 liuxb2009@hotmail.com
Contact: Jian-an Wang, MD,PhD +86-13805786328 Wang_jian_an@tom.com

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Principal Investigator: Jian-an Wang, MD,PhD Second Affiliated Hospital of Zhejiang University School of Medicine
  More Information

Responsible Party: Jian'an Wang,MD,PhD, President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT02803294     History of Changes
Other Study ID Numbers: SAHZJU CT006
First Submitted: June 7, 2016
First Posted: June 16, 2016
Last Update Posted: June 16, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction