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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07060183

Enrollment

Registered

2025-07-11

Start date

2027-01-31

Completion date

2029-02-28

Last updated

2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Aortic Valve Stenosis

Keywords

aortic, stenosis, valve, decompensation, moderate

Brief summary

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

Detailed description

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

Interventions

PROCEDURERoss procedure

aortic valve replacement

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 79 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Composite rates of all-cause mortality or morbidity	12 months	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.

Secondary

Measure	Time frame	Description
Left ventricular compensation	12 months	Improvement in left ventricular function from baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026