Aortic Valve Replacement for Moderate Aortic Stenosis With Left Ventricular Decompensation Early Feasibility Study

Dermed Diagnostics, Inc.

Overview

Obtain safety and effectiveness data to support expansion for aortic valve replacement to include patients with moderate aortic stenosis and left ventricular decompensation.

Single-center prospective study. Subjects with moderate aortic stenosis and left ventricular decompensation will receive aortic valve replacement by the Ross procedure.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Moderate Aortic Valve Stenosis

Interventions

Ross procedurePROCEDURE

aortic valve replacement

Eligibility

Sex: ALLMin age: 55 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate aortic stenosis, defined by transthoracic echocardiograph * Max aortic velocity less than 4.0 m/sec. * Mean aortic gradient less than 40.0 mmHg. * 1.0 cm2 \< Aortic Valve Area \< 1.5 cm2. * Left ventricular decompensation Exclusion Criteria: * Not suitable for the Ross procedure. * Documented history of cardiac amyloidosis.

Outcomes

Primary Outcomes

Composite rates of all-cause mortality or morbidity

Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to procedure-related complication, or valve dysfunction requiring reintervention.

Time frame: 12 months

Secondary Outcomes

Left ventricular compensation

Improvement in left ventricular function from baseline

Time frame: 12 months

Data from ClinicalTrials.gov

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