NCT07082426

Active Not Recruiting

Early System Experience With the Abbott Balloon-expandable T...

Abbott Medical Devices Source

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Other study identifiers

Sponsor study identifier

ABT-CIP-10542

Study Type

interventional

Actual enrollment (reported)

8

Locations

2 countries

Sites

3

Timeline

Study Start

November 21, 2024

Actual (reported)

Primary Completion

August 30, 2027

Estimated

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

Study Completion

September 2027

Estimated

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

Brief Summary

Early System Experience with the Abbott Balloon-expandable TAVI System

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): 8 participants
Study completion date: September 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 2 countries · 3 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.

Study Start
November 21, 2024
Actual (reported)
First Submitted
July 14, 2025
Actual (reported)
First Posted
July 24, 2025
Actual (reported)
Primary Completion
August 30, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: April 8, 2026
Status Verified: April 2026
Last Update Submitted: April 2, 2026

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

Balloon Expandable TAVITranscatheter aortic valve implantation (TAVI)Treatment of patients 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.
Post procedure
Device success
Intended performance of the valve
30 days

Study Arms (1)

Balloon expandable TAVI

EXPERIMENTAL

Device: Balloon expandable TAVI

Interventions

Balloon expandable TAVIDevice

Prospective, single-arm, multi-center early experience study.

Balloon expandable TAVI

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 VolunteersNo

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

You may qualify if:

Increased surgical risk
Appropriate anatomy

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (3)

Israeli - Georgian Medical Research Clinic Healthycore

Tbilisi, 0112, Georgia

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Republican Centre of Emergency Medicine

Tashkent, Toshknt, 100107, Uzbekistan

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

8 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 14, 2025

First Posted

July 24, 2025

Study Start

November 21, 2024

Actual (reported)

NCT04011722

Portico Next Generation Approval Study

Not ApplicableActive Not Recruiting

NCT01314313

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

Not ApplicableCompleted

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

At least 18 years of age

Willing to return for follow-up assessments

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

August 30, 2027

Estimated

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

Study Completion

September 2027

Estimated

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

Last Updated

April 8, 2026

Record last verified: 2026-04

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: NCT07082426
Data provider: ClinicalTrials.gov
Source updated: 2026-04-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:01 UTC

Locations

GE(2)UZ(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Balloon expandable TAVI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations