WithdrawnNot Applicable

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

Stopped: Lack of funding

0Started 2027-01

Plain-language summary

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

Who can participate

Age range55 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Composite rates of all-cause mortality or morbidity

Timeframe: 12 months

Trial details

NCT IDNCT07060183

SponsorDermed Diagnostics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Moderate Aortic Valve Stenosis trials