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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2026-05-30

Brief Summary

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Early System Experience with the Abbott Balloon-expandable TAVI System

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Detailed Description

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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.

Conditions

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Symptomatic Severe Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Balloon expandable TAVI

Group Type EXPERIMENTAL

Balloon expandable TAVI

Intervention Type DEVICE

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

Interventions

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Balloon expandable TAVI

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No