An interventional study of SAPIEN X4 THV and SAPIEN X4S in Aortic Stenosis, Severe, sponsored by Edwards Lifesciences. Recruiting at 65 sites in 4 countries. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
Among 41 studies in Aortic Valve Stenosis by Edwards Lifesciences — 4 open to participants now, 10 under way, none of them phase 3. Aortic Valve Stenosis · Edwards Lifesciences.
Among the 41 studies in Aortic Valve Stenosis by Edwards Lifesciences, this one is the 4th largest by planned enrollment of the 33 interventional ones that give a count, is one of 2 that started in 2022, is one of 33 with no phase, and was the 40th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 1,234 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →4 of the 41 studies in Aortic Valve Stenosis by Edwards Lifesciences are open now, in 7 countries. Each count lists the studies.
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →41 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2022.
Median enrollment 214 across the 33 interventional studies, 390 across the 8 observational. Of the 31 that completed or were terminated, 25 (81%) have results posted.
Edwards Lifesciences is the lead sponsor of 128 studies on the registry; 18 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 33 (94%) have results posted.
1 of the studies in Aortic Valve Stenosis by Edwards Lifesciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05172960Edwards LifesciencesALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve | 2027-07 |
Among the 41 studies in Aortic Valve Stenosis by Edwards Lifesciences, from their registry updates:
Nothing recorded among them since 2026-09-25.
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).
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will undergo transcatheter aortic valve replacement (TAVR)
Device: SAPIEN X4 THV
Subjects with bicuspid aortic valve morphology will undergo TAVR
Device: SAPIEN X4 THV
Subjects will undergo transcatheter aortic valve replacement (TAVR)
Device: SAPIEN X4S
Implantation of the SAPIEN X4 valve
Implantation of the SAPIEN X4S valve
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Time frame: 1 year
Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline
The number of patients that met all of these criteria. 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.
Time frame: 1 year
Paravalvular leak
Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe
Time frame: 30 days
New permanent pacemaker implantation
The number of patients with this event
Time frame: 30 days
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Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Jul 2027, 61 months after the start.
Of 111 industry-sponsored interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 61 months is above that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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