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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2027-01-31

Study Completion Date

2029-02-28

Brief Summary

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

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Detailed Description

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

Conditions

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Moderate Aortic Valve Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Aortic Valve Replacement

Group Type EXPERIMENTAL

Ross procedure

Intervention Type PROCEDURE

aortic valve replacement

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ross procedure

aortic valve replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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