Clinical trial · Interventional

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

NCT07060183CI-TRIAL-00092016withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Lack of funding

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Moderate Aortic Valve Stenosis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Ross procedure	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Intervention
description
Aortic Valve Replacement
interventionNames
1. Procedure: Ross procedure
type
NO_INTERVENTION
label
Control
description
No intervention

Primary outcomes (1)

measure
Composite rates of all-cause mortality or morbidity
timeFrame
12 months
description
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 outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 55 Years
Maximum age: 79 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.