NCT07116551

Active Not Recruiting

Early Feasibility Study (EFS) of Abbott's Balloon-expandable...

Abbott Medical Devices Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

ABT-CIP-10541

Study Type

interventional

Actual enrollment (reported)

11

Locations

2 countries

Sites

5

Timeline

Study Start

October 30, 2025

Actual (reported)

Primary Completion

June 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 11 participants
Study completion date: June 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 2 countries · 5 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 22, 2025
Actual (reported)
First Posted
August 11, 2025
Actual (reported)
Study Start
October 30, 2025
Actual (reported)
Primary Completion
June 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: February 6, 2026
Status Verified: February 2026
Last Update Submitted: February 5, 2026

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

Balloon Expandable TAVITAVITreatment of patient with symptomatic severe aortic valve stenosisaortic stenosiscardiovascular disease

Outcome Measures

Primary Outcomes (2)

Technical success
Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
From start of procedure up to end of procedure
Device success
Intended performance of the valve
30 days

Study Arms (1)

BE TAVI System

EXPERIMENTAL

BE TAVI System

Device: Abbott BE TAVI System

Interventions

Abbott BE TAVI SystemDevice

Abbott BE TAVI System

BE TAVI System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject is at least 18 years of age
Subject is able and willing to return for required follow-up visits and assessments

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (5)

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Columbia University Medical Center/New York-Presbyterian

New York, New York, 10032, United States

Montefiore Medical Center - Moses Division

The Bronx, New York, 10461, United States

Clinique Pasteur Toulouse

Toulouse, Midpyre, 31076, France

MeSH Terms

Conditions

Aortic Valve StenosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesVentricular Outflow Obstruction

Study Officials

Ashish Oza
Abbott Structural Heart
STUDY DIRECTOR

Enrollment

11 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DEVICE FEASIBILITY
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 11, 2025

Study Start

October 30, 2025

Actual (reported)

NCT04011722

Portico Next Generation Approval Study

Not ApplicableActive Not Recruiting

NCT03222128

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate

Not ApplicableCompleted

NCT03222141

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

Not ApplicableCompleted

NCT01314313

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

Not ApplicableCompleted

Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria

You may not qualify if:

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
Liver failure
Severe mitral regurgitation or severe mitral stenosis
etc.

Contact the study team to confirm eligibility.

Primary Completion

June 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

February 6, 2026

Record last verified: 2026-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07116551
Data provider: ClinicalTrials.gov
Source updated: 2026-02-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:08 UTC

Locations

FR(1)US(4)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

BE TAVI System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations