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Active, Not Recruiting

NCT Number: NCT07082426

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

Early System Experience with the Abbott Balloon-expandable TAVI System

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Symptomatic Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Israeli - Georgian Medical Research Clinic Healthycore, Tbilisi, Georgia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balloon expandable TAVI

Device

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

Primary outcomes

  1. Technical Success

    Time frame: Post procedure

    Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.

  2. Device success

    Time frame: 30 days

    Intended performance of the valve

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: EASE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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