CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

Sorin

Status: Terminated

Conditions: Aortic Valve Disease

Treatments: Device: Regent; Device: Top Hat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619151

RVSS-1H

Details and patient eligibility

About

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.

Exclusion criteria

• Patients < 18 years of age
• Emergency surgery
• Pre-existing valve prosthesis
• Aortic root replacement
• Active endocarditis

Trial design

2 participants in 2 patient groups

1

Active Comparator group

Description:

CarboMedics Supra-annular Top Hat Valve

Treatment:

Device: Top Hat

2

Active Comparator group

Description:

St. Jude Medical Regent Valve

Treatment:

Device: Regent