Aortic Valve Replacement for Moderate Aortic Stenosis Wit... | NCT07060183

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

NCT07060183

Sponsor

Dermed Diagnostics, Inc.

Status

Withdrawn

Last Update Posted

Jul 11, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Moderate Aortic Valve Stenosis

Interventions

Ross procedure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Jan 2027Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Feb 2029Estimated

First Submitted Date

Apr 25, 2023

First Submission Date that Met QC Criteria

Jul 8, 2025

First Posted Date

Jul 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2025

Last Update Posted Date

Jul 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Aortic Valve Replacement	Procedure: Ross procedure
Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ross procedure	Procedure	aortic valve replacement	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Arthur P DeMarzo	Dermed Diagnostics, Inc.	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003251	Constriction, Pathologic
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma

Browse Leaves

Not provided

Browse Branches

Not provided