PARTNER 3 Trial - Aortic Valve-in-Valve
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|ClinicalTrials.gov Identifier: NCT03003299|
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : April 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Aortic Stenosis, Severe||Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve|
|Actual Study Start Date :||January 5, 2017|
|Estimated Primary Completion Date :||January 2033|
|Estimated Study Completion Date :||April 2038|
Experimental: TAVR - Failing surgical or transcatheter valve
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
- Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke [ Time Frame: 1 year ]Number of patients that died and/or had a stroke
- Mean gradient [ Time Frame: 30 days ]Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
- Peak gradient [ Time Frame: 30 days ]Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 30 days ]Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
- New York Heart Association (NYHA) Classification [ Time Frame: 30 days ]Change from baseline in NYHA. 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.
- Six-Minute Walk Test (6MWT) [ Time Frame: 30 days ]Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
- Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
- NYHA Functional Class ≥ II.
- Heart Team agrees the patient is low to intermediate risk.
- Heart Team agrees valve implantation will likely benefit the patient.
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
- Severe regurgitation (> 3+) or stenosis of any other valve
- Failing valve has moderate or severe paravalvular regurgitation
- Failing valve is unstable, rocking, or not structurally intact
- Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
- Increased risk of embolization of THV
- Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
- Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
- Anatomical characteristics that would preclude safe access to the apex (Transapical)
- Evidence of an acute myocardial infarction ≤ 30 days before enrollment
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
- Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- Untreated clinically significant coronary artery disease requiring revascularization
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
- Emergency interventional/surgical procedures within 30 days prior to the procedure
- Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
- Hypertrophic cardiomyopathy with obstruction
- LVEF < 30%
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- Stroke or transient ischemic attack within 90 days of enrollment
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
- Renal insufficiency and/or renal replacement therapy at the time of screening
- Active bacterial endocarditis within 180 days of the procedure
- Patient refuses blood products
- Estimated life expectancy < 24 months
- Positive urine or serum pregnancy test in female subjects of childbearing potential
- Currently participating in an investigational drug or another device study
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
|Contact: Edwards THV Clinical Affairs||(949) 250-2500||THV_CT.gov@Edwards.com|
|Principal Investigator:||Chris S Malaisrie, MD||Northwestern University Feinberg School of Medicine|
|Principal Investigator:||Alan Zajarias, MD||Washington University School of Medicine|
|Principal Investigator:||Mayra Guerrero, MD||Mayo Clinic|
|Responsible Party:||Edwards Lifesciences|
|Other Study ID Numbers:||
|First Posted:||December 28, 2016 Key Record Dates|
|Last Update Posted:||April 14, 2022|
|Last Verified:||April 2022|
|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|
failing surgical valve
failing bioprosthetic valve
SAPIEN 3 Ultra
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction