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

N/AActive Not RecruitingNCT07082426

Abbott Medical Devices8 enrolled

Overview

Early System Experience with the Abbott Balloon-expandable TAVI System

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Symptomatic Severe Aortic Stenosis

Interventions

Balloon expandable TAVIDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Israeli - Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Republican Centre of Emergency Medicine

Tashkent, Toshknt, Uzbekistan

Outcomes

Primary Outcomes

Technical Success

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

Time frame: Post procedure

Device success

Intended performance of the valve

Time frame: 30 days

Data from ClinicalTrials.gov

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