Symptomatic Severe Aortic StenosisNCT07116551
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
A study testing Abbott BE TAVI System in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- Abbott BE TAVI System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Oct 2025to Jun 2031
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age
- Subject is able and willing to return for required follow-up visits and assessments
- Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria
Who cannot join
- Pregnant or nursing subjects
- Life expectancy for a condition other than aortic stenosis is less than 2 years
- Presence of other anatomic or comorbid conditions
- Incapacitated individuals
- Evidence of an acute myocardial infarction
- Untreated clinically significant coronary artery disease requiring revascularization
Show all 9Show fewer
- Liver failure
- Severe mitral regurgitation or severe mitral stenosis
- etc.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Columbia University Medical Center/New York-Presbyterian
New York, New York, 10032
Montefiore Medical Center - Moses Division
The Bronx, New York, 10461
Via Christi Regional Medical Center
Wichita, Kansas, 67214
About this study
Official title: Abbott BE TAVI Early Feasibility Study: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
Read the detailed description
The EFS will evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Conditions
- Symptomatic Severe Aortic Stenosis
- Being tested
- Abbott BE TAVI System
- Keywords
- Balloon Expandable TAVI, TAVI, Treatment of patient with symptomatic severe aortic valve stenosis, aortic stenosis, cardiovascular disease
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott BE TAVI SystemDevice
Abbott BE TAVI System
| Study group | Role | What they receive |
|---|---|---|
| BE TAVI System | Experimental | BE TAVI System Receives: Device: Abbott BE TAVI System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
Measured: From start of procedure up to end of procedure
Device success
Intended performance of the valve
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Oct 2025
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashish Oza, Study director, Abbott Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116551
- Sponsor's protocol ID
- ABT-CIP-10541
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbott BE TAVI Early Feasibility Study: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
- ClinicalTrials.gov ID
- NCT07116551
- Acronym / sponsor ID
- ABT-CIP-10541
- Conditions
- Symptomatic Severe Aortic Stenosis
- Keywords
- Balloon Expandable TAVI, TAVI, Treatment of patient with symptomatic severe aortic valve stenosis, aortic stenosis, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 11 Aug 2025 (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.
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
Detailed description
The EFS will evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BE TAVI System | Experimental | Device: Abbott BE TAVI SystemBE TAVI System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is at least 18 years of age
- Subject is able and willing to return for required follow-up visits and assessments
- Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria
Key exclusion criteria (9 listed)
- Pregnant or nursing subjects
- Life expectancy for a condition other than aortic stenosis is less than 2 years
- Presence of other anatomic or comorbid conditions
- Incapacitated individuals
- Evidence of an acute myocardial infarction
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 |
|---|---|---|
| Abbott BE TAVI SystemAbbott BE TAVI System | Device | BE TAVI System |
Primary outcome
Technical success
Time frame: From start of procedure up to end of procedure
Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
Device success
Time frame: 30 days
Intended performance of the valve
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 6 Feb 2026.
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ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
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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.
Ashish Oza study director
Abbott Structural Heart
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott BE TAVI System in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 5 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, France. 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?
Technical success (time frame: From start of procedure up to end of procedure). The study lists 2 primary outcomes in all. 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 6 Feb 2026.