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New treatment option for Aortic Stenosis
Official title PARTNER 3 Trial - Aortic Valve-in-Valve
ClinicalTrials.gov ID: NCT03003299
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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 treatment/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 people of childbearing potential
- Currently participating in an investigational drug or another device study
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Loveland, Colorado, United States
- Hartford, Connecticut, United States
- Atlantis, Florida, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Springfield, Illinois, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Sacramento, California, United States; San Francisco, California, United States; Stanford, California, United States; Loveland, Colorado, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.