Symptomatic Severe Aortic StenosisEASENCT07082426
Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
A study testing Balloon expandable TAVI in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 3 sites in 2 countries.
Trial summary
Early System Experience with the Abbott Balloon-expandable TAVI System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- Balloon expandable TAVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Nov 2024to Sep 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Increased surgical risk
- Appropriate anatomy
- At least 18 years of age
- Willing to return for follow-up assessments
Who cannot join
- Pregnant or nursing subjects
- Anatomic or comorbid conditions
- Evidence of acute myocardial infarction
- Inoperable/ineligible for surgery
- Renal disease requiring chronic dialysis
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Georgia2 sites
Israeli - Georgian Medical Research Clinic Healthycore
Tbilisi, 0112
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
Uzbekistan1 site
Republican Centre of Emergency Medicine
Tashkent, Toshknt, 100107
About this study
Official title: EASE Study: Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
Early System Experience with the Abbott Balloon-expandable TAVI System
Read the detailed description
The Early System Experience with the Abbott's balloon-expandable TAVI System first-in-human study ('EASE study') will evaluate preliminary clinical evidence on the safety and feasibility of the Abbott's balloon-expandable TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Conditions
- Symptomatic Severe Aortic Stenosis
- Being tested
- Balloon expandable TAVI
- Keywords
- Balloon Expandable TAVI, Transcatheter aortic valve implantation (TAVI), Treatment of patients 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.
Balloon expandable TAVIDevice
Prospective, single-arm, multi-center early experience study.
| Study group | Role | What they receive |
|---|---|---|
| Balloon expandable TAVI | Experimental | Not described Receives: Device: Balloon expandable TAVI |
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: Post 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 posted24 Jul 2025
- Study start21 Nov 2024
- Primary completion30 Aug 2027 (estimated)
- Study completionSep 2027 (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
- 8 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
- NCT07082426
- Sponsor's protocol ID
- ABT-CIP-10542
- Acronym
- EASE
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2025
- Last updated
- 8 Apr 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASE Study: Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
- ClinicalTrials.gov ID
- NCT07082426
- Acronym / sponsor ID
- EASE / ABT-CIP-10542
- Conditions
- Symptomatic Severe Aortic Stenosis
- Keywords
- Balloon Expandable TAVI, Transcatheter aortic valve implantation (TAVI), Treatment of patients with symptomatic severe aortic valve stenosis, Aortic stenosis, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Jul 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.
Early System Experience with the Abbott Balloon-expandable TAVI System
Detailed description
The Early System Experience with the Abbott's balloon-expandable TAVI System first-in-human study ('EASE study') will evaluate preliminary clinical evidence on the safety and feasibility of the Abbott's balloon-expandable 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 |
|---|---|---|
| Balloon expandable TAVI | Experimental | Device: Balloon expandable TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Increased surgical risk
- Appropriate anatomy
- At least 18 years of age
- Willing to return for follow-up assessments
Key exclusion criteria (5 listed)
- Pregnant or nursing subjects
- Anatomic or comorbid conditions
- Evidence of acute myocardial infarction
- Inoperable/ineligible for surgery
- Renal disease requiring chronic dialysis
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 |
|---|---|---|
| Balloon expandable TAVIProspective, single-arm, multi-center early experience study. | Device | Balloon expandable TAVI |
Primary outcome
Technical Success
Time frame: Post 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 8 Apr 2026.
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DurAVR™ THV EU-EFS
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Portico Next Generation Approval Study
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Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
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DurAVR™ THV System: EMBARK Study
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon expandable TAVI in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 3 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 4 inclusion and 5 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 8 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 3 sites in Georgia, Uzbekistan. 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: Post 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 8 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.