Early System Experience With the Abbott Balloon-expandabl... | NCT07082426

Studies
Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study

NCT07082426

Sponsor

Abbott Medical Devices

Status

Active, not recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Symptomatic Severe Aortic Stenosis

Interventions

Balloon expandable TAVI

Countries

Georgia
Uzbekistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2024Actual

Primary Completion Date

Aug 30, 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Jul 14, 2025

First Submission Date that Met QC Criteria

Jul 16, 2025

First Posted Date

Jul 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Balloon expandable TAVI	Experimental		Device: Balloon expandable TAVI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Balloon expandable TAVI	Device	Prospective, single-arm, multi-center early experience study.	Balloon expandable TAVI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Technical Success	Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.	Post procedure
Device success	Intended performance of the valve	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Increased surgical risk
Appropriate anatomy
At least 18 years of age
Willing to return for follow-up assessments

Exclusion Criteria:

Pregnant or nursing subjects
Anatomic or comorbid conditions
Evidence of acute myocardial infarction
Inoperable/ineligible for surgery
Renal disease requiring chronic dialysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ashish Oza	Abbott Structural Heart	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Israeli - Georgian Medical Research Clinic Healthycore		Tbilisi		0112	Georgia
Tbilisi Heart and Vascular Clinic

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D014694	Ventricular Outflow Obstruction

Browse Leaves

Not provided

Browse Branches

Not provided