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

Abbott

Status: Active, not recruiting

Conditions: Symptomatic Severe Aortic Stenosis

Treatments: Device: Balloon expandable TAVI

Study type: Interventional

Funder types: Industry

Identifiers

NCT07082426

ABT-CIP-10542

Details and patient eligibility

About

Early System Experience with the Abbott Balloon-expandable TAVI System

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Balloon expandable TAVI

Experimental group

Treatment:

Device: Balloon expandable TAVI