NCT07082426

Brief Summary

Early System Experience with the Abbott Balloon-expandable TAVI System

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Nov 2024Sep 2027

Study Start

First participant enrolled

November 21, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

July 14, 2025

Last Update Submit

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Increased surgical risk
  • Appropriate anatomy
  • 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.

Sponsors & Collaborators

Study Sites (3)

Israeli - Georgian Medical Research Clinic Healthycore

Tbilisi, 0112, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Location

Republican Centre of Emergency Medicine

Tashkent, Toshknt, 100107, Uzbekistan

Location

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

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

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

UZ(1)GE(2)