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The PARTNER 3 - AVIV Trial (P3-AVIV)

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ClinicalTrials.gov Identifier: NCT03003299
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

December 19, 2016
December 28, 2016
November 22, 2017
January 5, 2017
October 5, 2018   (Final data collection date for primary outcome measure)
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 %.
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 %.
Complete list of historical versions of study NCT03003299 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
The PARTNER 3 - AVIV Trial
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
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.
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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Aortic Stenosis
  • Cardiomyopathy, Hypertrophic
Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Other Name: TAVI
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
Same as current
March 5, 2027
October 5, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact: Justine Encabo 949-250-3502 Justine_Encabo@edwards.com
Contact: Vinny Podichetty, MD 949-250-5794 Vinny_Podichetty@edwards.com
Canada,   United States
 
 
NCT03003299
2015-08 AVIV
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Chris S Malaisrie, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Alan Zajarias, MD Washington University School of Medicine
Edwards Lifesciences
November 2017

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