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Trial record 14 of 221 for:    heart disease AND stroke AND California

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

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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Cardiomyopathy, Hypertrophic Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : October 5, 2018
Estimated Study Completion Date : March 5, 2027


Arm Intervention/treatment
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.
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 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.
Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Other Name: TAVI



Primary Outcome Measures :
  1. 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 %.


Secondary Outcome Measures :
  1. Mean gradient [ Time Frame: 30 days ]
    Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.

  2. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03003299


Contacts
Contact: Justine Encabo 949-250-3502 Justine_Encabo@edwards.com
Contact: Vinny Podichetty, MD 949-250-5794 Vinny_Podichetty@edwards.com

  Show 53 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Chris S Malaisrie, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Alan Zajarias, MD Washington University School of Medicine

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03003299     History of Changes
Other Study ID Numbers: 2015-08 AVIV
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Edwards Lifesciences:
Sapien 3
Partner 3
cardiovascular disease
heart disease
aortic stenosis
SAVR
TAVR
failing surgical valve
failing bioprosthetic valve
failing valve

Additional relevant MeSH terms:
Cardiomyopathies
Aortic Valve Stenosis
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular