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Tests treatment safety and results for Aortic Stenosis, Severe
Official title ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
ClinicalTrials.gov ID: NCT05172960
What this study is testing
- What it's testing
- The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
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
- Severe, calcific AS
- Native aortic annulus size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
You likely can't join if
- Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
- Severe aortic regurgitation (\> 3+)
- Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
- Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
See the full eligibility criteria
- Severe, calcific AS
- Native aortic annulus size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
- Severe aortic regurgitation (\> 3+)
- Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
- Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
- Left ventricular ejection fraction \< 20%
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
- Increased risk of coronary artery obstruction after THV implantation
- Myocardial infarction within 30 days prior to the study procedure
- Hypertrophic cardiomyopathy with subvalvular obstruction
- people with planned concomitant ablation for atrial fibrillation
- Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
- Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator...
- Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
- Endocarditis within 180 days prior to the study procedure
- Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
- Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
- Renal insufficiency and/or renal replacement therapy
- Leukopenia, anemia, thrombocytopenia
- Inability to tolerate or condition precluding treatment with antithrombotic therapy
- Hypercoagulable state or other condition that increases risk of thrombosis
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- Subject refuses blood products
- BMI \> 50 kg/m2
- Estimated life expectancy \< 24 months
- Female who is pregnant or lactating
- Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Participating in another investigational drug or device study that has not reached its primary endpoint
- Subject considered to be part of a vulnerable population
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Loveland, Colorado, United States
- Hartford, Connecticut, United States
- North Naples, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Elk Grove Village, Illinois, United States
- Evanston, Illinois, United States
- New Lenox, Illinois, United States
- Carmel, Indiana, United States
- Kansas City, Kansas, United States
- Wichita, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
+ 34 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 La Jolla, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Sacramento, California, United States; San Francisco, California, United States; Stanford, California, United States and 48 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.