NCT07060183

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
25mo left

Started Jan 2027

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

April 25, 2023

Last Update Submit

July 8, 2025

Conditions

Moderate Aortic Valve Stenosis

Keywords

aorticstenosisvalvedecompensationmoderate

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Left ventricular compensation

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Aortic Valve Replacement

Procedure: Ross procedure

Control

NO INTERVENTION

No intervention

Interventions

Ross procedurePROCEDURE

aortic valve replacement

Intervention

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate aortic stenosis, defined by transthoracic echocardiograph
  • Max aortic velocity less than 4.0 m/sec.
  • Mean aortic gradient less than 40.0 mmHg.
  • cm2 \< Aortic Valve Area \< 1.5 cm2.
  • Left ventricular decompensation

You may not qualify if:

  • Not suitable for the Ross procedure.
  • Documented history of cardiac amyloidosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constriction, PathologicLymphoma, Follicular

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Arthur P DeMarzo

    Dermed Diagnostics, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

July 11, 2025

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share