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The PARTNER 3 - AVIV Trial (P3-AVIV)

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.
 
ClinicalTrials.gov Identifier: NCT03003299
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE December 19, 2016
First Posted Date  ICMJE December 28, 2016
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE January 5, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
Safety and Effectiveness - composite endpoint of all-cause mortality and stroke [ Time Frame: 1 year ]
Non-hierarchical composite of all-cause mortality and stroke. Measured in %.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
Safety and Effectiveness - composite endpoint of all-cause mortality and stroke [ Time Frame: 1 year ]
Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications. Measured in %.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Mean gradient [ Time Frame: 30 days ]
    Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
  • New York Heart Association (NYHA) Classification [ Time Frame: 30 days ]
    New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
  • Mean gradient [ Time Frame: 30 days ]
    Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
  • New York Heart Association (NYHA) Classification [ Time Frame: 30 days ]
    NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PARTNER 3 - AVIV Trial
Official Title  ICMJE P3-AVIV is a Prospective, Single-arm, Multicenter Clinical Trial That Will Establish the Safety and Efficacy of SAPIEN 3 THV in Patients With a Failing Aortic Bioprosthetic Valve
Brief Summary To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.
Detailed Description A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Stenosis
  • Cardiomyopathy, Hypertrophic
Intervention  ICMJE Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Other Name: TAVI
Study Arms  ICMJE
  • Experimental: Failing surgical valve
    Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
    Intervention: Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
  • Experimental: Failing transcatheter valve
    Patients with a failing transcatheter bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
    Intervention: Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2016)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 5, 2027
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  2. Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
  3. NYHA Functional Class ≥ II.
  4. Heart Team agrees valve implantation will likely benefit the patient.
  5. 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. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
  2. Severe regurgitation (>3+) or stenosis of any other valve.
  3. Failing valve has paravalvular regurgitation (includes those instances that have been previously treated with a plug due to paravalvular regurgitation).
  4. Failing valve is unstable, rocking, or not structurally intact.
  5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
  6. Increased risk of embolization of THV (e.g., surgical valve that is non-stented and non-calcified).
  7. Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index procedure for implantation of the original valve.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Justine Encabo 949-250-3502 Justine_Encabo@edwards.com
Contact: Vinny Podichetty, MD 949-250-5794 Vinny_Podichetty@edwards.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03003299
Other Study ID Numbers  ICMJE 2015-08 AVIV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chris S Malaisrie, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Alan Zajarias, MD Washington University School of Medicine
PRS Account Edwards Lifesciences
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP