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

Dermed Diagnostics, Inc.

Status: Withdrawn

Conditions: Moderate Aortic Valve Stenosis

Treatments: Procedure: Ross procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT07060183

Moderate Aortic Stenosis AVR

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

Aortic Valve Replacement

Treatment:

Procedure: Ross procedure

Control

No Intervention group

Description:

No intervention