Aortic Valve InsufficiencyNCT05172973
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
A study testing SAPIEN X4/X4S THV in people with Aortic Valve Insufficiency and Aortic Valve Stenosis, run by Edwards Lifesciences at 37 sites in 2 countries.
Trial summary
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Insufficiency, Aortic Valve Stenosis
- What is being tested?
- SAPIEN X4/X4S THV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 22 Nov 2023to Dec 2039
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Bioprosthetic valve size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
- Heart Team agrees the subject is at high or greater surgical risk
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- Failing valve has moderate or severe paravalvular regurgitation
- Failing valve is unstable, rocking, or not structurally intact
- Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
- Increased risk of THV embolization
- Surgical or transcatheter valve in the mitral position
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- 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
- Increased risk of coronary artery obstruction after THV implantation
- Myocardial infarction within 30 days prior to the study procedure
- Hypertrophic cardiomyopathy with subvalvular obstruction
- Subjects with planned concomitant ablation for atrial fibrillation
- Clinically significant coronary artery disease requiring revascularization
- Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
- Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
- 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
- Body mass index > 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
Trial locations and contacts
37 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 2 countries
United States34 sites, 27 recruiting
- Recruiting
Emory University Atlanta
Atlanta, Georgia, 30308
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
- Recruiting
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
- Withdrawn
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
University of Buffalo
Buffalo, New York, 14203
- Active, not recruiting
Carolinas Health System
Charlotte, North Carolina, 28204
- Recruiting
Novant Health and Vascular Institute
Charlotte, North Carolina, 28204
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
Kaiser Portland
Clackamas, Oregon, 97015
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Henry Ford Hospital Detroit
Detroit, Michigan, 48202
- Recruiting
Northwestern University Chicago
Evanston, Illinois, 60208
- Active, not recruiting
University of Texas Memorial Hermann
Houston, Texas, 77030
- Recruiting
Alexian Brothers Hospital Network
Lisle, Illinois, 60532
- Recruiting
UC Health Medical Center of the Rockies
Loveland, Colorado, 80538
- Recruiting
Atlantic Health System Morristown
Morristown, New Jersey, 07960
- Recruiting
Naples Community Hospital Healthcare System
Naples, Florida, 34102
- Recruiting
Saint Thomas Health
Nashville, Tennessee, 37205
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
- Recruiting
Cornelll University New York
New York, New York, 10021
- Recruiting
Columbia University Medical Center / NYPH
New York, New York, 10032
- Recruiting
Montefiore Medical Center
New York, New York, 10458
- Withdrawn
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
- Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, 75093
- Withdrawn
The Valley Hospital
Ridgewood, New Jersey, 07450
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Rochester General Hospital
Rochester, New York, 14621
- Recruiting
Bay Area Structural Heart at Sutter Health
San Francisco, California, 94105
- Active, not recruiting
Kaiser San Francisco
San Francisco, California, 94115
- Withdrawn
University of Washington Seattle
Seattle, Washington, 98195
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
- Recruiting
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
- Recruiting
Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas)
Wichita, Kansas, 67226
Canada3 sites, 3 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval
Québec, G1V4G5
- Recruiting
St. Paul's Hospital Vancouver
Vancouver, British Columbia, V6Z1Y6
About this study
Official title: Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
Read the detailed description
Prospective, single arm, multicenter study
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Stenosis
- Being tested
- SAPIEN X4/X4S THV
- Keywords
- Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), SAPIEN X4/X4S, Valve-in-valve
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN X4/X4S THVDevice
Implantation of the SAPIEN X4/X4S valve
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve | Experimental | TAVR implant in subjects with a failing aortic surgical valve. Receives: Device: SAPIEN X4/X4S THV |
| Transcatheter Aortic Valve Replacement (TAVR) - THV | Experimental | TAVR implant in subjects with a failing aortic transcatheter heart valve (THV). Receives: Device: SAPIEN X4/X4S THV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Measured: 1 year
Secondary outcomes (4)
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: 30 days
KCCQ score
Measured: 1 year
New York Heart Association (NYHA) functional class
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.
Measured: 30 days
NYHA functional class
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start22 Nov 2023
- Primary completionMar 2029 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Cubbedu, MD, Principal investigator, Naples Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172973
- Sponsor's protocol ID
- 2021-05-AVIV
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No