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Trial record 6 of 371 for:    aortic valve replacement

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2016 by Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor:
Information provided by (Responsible Party):
Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT02803294
First received: June 7, 2016
Last updated: June 13, 2016
Last verified: June 2016
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Second Affiliated Hospital, School of Medicine, Zhejiang University:

Primary Outcome Measures:
  • Death from any cause [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • stroke [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
  • death from cardiac causes [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
  • repeated hospitalization [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years, 10 years ] [ Designated as safety issue: Yes ]
  • acute kidney injury [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
  • vascular complications [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
  • bleeding events [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
  • device success [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • permanent pacemaker implantation [ Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Death from all causes [ Time Frame: 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years,10 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 7, 2016
Last Updated: June 13, 2016
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016