Aortic Valve StenosisNCT03471065
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
A study testing SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV in people with Aortic Valve Stenosis, run by Edwards Lifesciences at 6 sites in 2 countries.
Trial summary
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Jun 2018to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
- Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2
- Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
- New York Heart Association functional class ≥ II
- Judged by the Heart Team to be at intermediate risk for open surgical therapy
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
- 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 stenosis
- Ventricular dysfunction with left ventricular ejection fraction < 30%
Show all 34Show fewer
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
- Subjects with planned concomitant ablation for atrial fibrillation
- Hypertrophic cardiomyopathy with obstruction
- Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
- Complex coronary artery disease:
- Unprotected left main coronary artery
- SYNTAX score > 32
- Heart Team assessment that optimal revascularization cannot be performed
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath
- Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
- Active bacterial endocarditis within 180 days of the valve implant procedure
- Stroke or transient ischemic attack within 90 days of the valve implant procedure
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
- Severe lung disease (Forced Ejection Volume 1 < 50% predicted) or currently on home oxygen
- Severe pulmonary hypertension
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
- History of cirrhosis or any active liver disease
- Renal insufficiency and/or renal replacement therapy at the time of screening
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Significant frailty as determined by the Heart Team
- Subject refuses blood products
- Body mass index > 50 kg/m2
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada4 sites
Hamilton Health Sciences
Hamilton, Ontario
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec
Toronto General Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
About this study
Official title: A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra System in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Conditions
- Aortic Valve Stenosis
- Being tested
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Keywords
- Transcatheter, Transcatheter Valve Replacement, SAPIEN 3 Ultra
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THVDevice
Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | Not described Receives: Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room:
- Mortality
- Conversion to surgery
- Moderate or severe paravalvular regurgitation
Measured: Day 0
Secondary outcomes (2)
Major Vascular Complications
Number of patients with major vascular complications
Measured: Discharge, expected to be within 1-5 days post-procedure]
Valve Migration or Embolization
Number of patients with valve migration or embolization
Measured: Discharge, expected to be within 1-5 days post-procedure]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Jun 2018
- Primary completion23 Dec 2019
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve StenosisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- SAPIEN 3 Ultra System
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Webb, MD, Principal investigator, St. Paul's HospitalBernard Prendergast, Prof, Principal investigator, St. Thomas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471065
- Sponsor's protocol ID
- 2018-03
- Status last verified
- May 2025
- First submitted
- 5 Mar 2018
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra System in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03471065
- Acronym / sponsor ID
- 2018-03
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter, Transcatheter Valve Replacement, SAPIEN 3 Ultra
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Posted 19 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SAPIEN 3 Ultra System
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
- New York Heart Association functional class ≥ II
- Judged by the Heart Team to be at intermediate risk for open surgical therapy
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Key exclusion criteria (34 listed)
- Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
- 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 stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THVPatients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System. | Device | Transcatheter Aortic Valve Replacement (TAVR) |
Primary outcome
Procedural Success
Time frame: Day 0
The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation
2 secondary outcomes
Major Vascular Complications
Time frame: Discharge, expected to be within 1-5 days post-procedure]
Valve Migration or Embolization
Time frame: Discharge, expected to be within 1-5 days post-procedure]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Webb, MD principal investigator
St. Paul's Hospital
Bernard Prendergast, Prof principal investigator
St. Thomas Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV in people with Aortic Valve Stenosis, run by Edwards Lifesciences at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.