Aortic Valve StenosisNCT04555967
SAPIEN 3 Ultra System PMCF
An observational study of Aortic Valve Stenosis, run by Edwards Lifesciences at 11 sites in 8 countries.
Trial summary
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis. 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 System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 11 sitesin 8 countries
- Study dates
- 30 Jun 2020to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subjects with symptomatic, severe, calcific aortic stenosis treated per the indications for use in the Instructions for Use
- Subject meets the criteria per the Indication and Contraindications according to the current IFUs.
- Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator).
- Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy.
- Subject has provided written informed consent to comply with all study procedures and follow-up visits
Trial locations and contacts
11 sites in 8 countries.
11 sites in 8 countries
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Deutsches Herzzentrum Berlin
Berlin, 13353
Universitares Herzzentrum Hamburg
Hamburg, 20251
United Kingdom2 sites
Royal Victoria Hospital Belfast
Belfast, BT12 6BA
King's College Hospital London
London, SE5 9RS
Canada1 site
St. Paul's Hospital Vancouver
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Read the detailed description
To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
- Conditions
- Aortic Valve Stenosis
- Being tested
- SAPIEN 3 Ultra System
- Keywords
- Transcatheter Aortic Valve Implantation, Transcatheter Aortic 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 SystemDevice
Transcatheter aortic valve implantation
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter aortic valve implantation | Not described Receives: Device: SAPIEN 3 Ultra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success per VARC-3, defined as meeting all of the following:
- Technical success
- Freedom from mortality
- Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
- Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
Measured: 30 days
Secondary outcomes (10)
Death
Measured: 1 year
Stroke
Measured: 30 days and 1 year
Major vascular complications
Measured: 30 days
Life threatening bleeding
Measured: 30 days
New conduction defects requiring permanent pacemaker
Measured: 30 days
Acute kidney injury stage 2-3
Measured: 7 days
New onset atrial fibrillation
Measured: 30 days
Rehospitalization (valve-related or due to worsening heart failure)
Measured: 1 year
Paravalvular leak
Measured: 30 days and 1 year
Mean aortic valve gradient
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start30 Jun 2020
- Primary completion24 Sep 2021
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555967
- Sponsor's protocol ID
- 2018-09
- Status last verified
- Apr 2026
- First submitted
- 1 Sep 2020
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04555967
- Acronym / sponsor ID
- 2018-09
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, SAPIEN 3 Ultra
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Detailed description
To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter aortic valve implantation | – | Device: SAPIEN 3 Ultra System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with symptomatic, severe, calcific aortic stenosis treated per the indications for use in the Instructions for Use
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 SystemTranscatheter aortic valve implantation | Device | Transcatheter aortic valve implantation |
Primary outcome
Device success per VARC-3, defined as meeting all of the following:
Time frame: 30 days
* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication * Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
10 secondary outcomes
Death
Time frame: 1 year
Stroke
Time frame: 30 days and 1 year
Major vascular complications
Time frame: 30 days
Life threatening bleeding
Time frame: 30 days
New conduction defects requiring permanent pacemaker
Time frame: 30 days
Acute kidney injury stage 2-3
Time frame: 7 days
New onset atrial fibrillation
Time frame: 30 days
Rehospitalization (valve-related or due to worsening heart failure)
Time frame: 1 year
Paravalvular leak
Time frame: 30 days and 1 year
Mean aortic valve gradient
Time frame: 30 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Edwards Lifesciences at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, United Kingdom, Austria, Canada, Denmark and 3 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Device success per VARC-3, defined as meeting all of the following: (time frame: 30 days). 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 15 Apr 2026.