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Trial record 66 of 228 for:    Recruiting, Not yet recruiting, Available Studies | Aortic stenosis

The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis

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. Identifier: NCT03163329
Recruitment Status : Not yet recruiting
First Posted : May 23, 2017
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):
Yongjian Wu, China National Center for Cardiovascular Diseases

Brief Summary:
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Procedure: TAVR Procedure: SAVR Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TAVR group Procedure: TAVR
Transcatheter Aortic Valve Replacement

Active Comparator: SAVR group Procedure: SAVR
Surgical Aortic Valve Replacement

Primary Outcome Measures :
  1. All-cause mortality, all stroke, and re-hospitalization [ Time Frame: 1 year post procedure ]
    This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35%

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Severe, calcific bicuspid aortic stenosis.
  2. Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >3.
  3. 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.

Exclusion Criteria:

  1. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
  2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
  3. Severe aortic regurgitation (>3+).
  4. Severe mitral regurgitation (>3+).

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 identifier (NCT number): NCT03163329

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Contact: Yong-jian Wu, M.D, Ph.D 0086-10-88396780

Sponsors and Collaborators
China National Center for Cardiovascular Diseases

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Responsible Party: Yongjian Wu, Clinical Professor, China National Center for Cardiovascular Diseases Identifier: NCT03163329     History of Changes
Other Study ID Numbers: AS-20170520
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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