RecruitingNot ApplicableNCT03003299
PARTNER 3 Trial - Aortic Valve-in-Valve
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
Sponsor
Edwards Lifesciences
Enrollment
125 participants
Start Date
Jan 5, 2017
Study Type
INTERVENTIONAL
Conditions
Summary
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria31
- 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
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Interventions
DEVICEEdwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Locations(51)
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NCT03003299
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