Hemodynamic Performance in Stentless Heart Valves

University of Aarhus

Status: Completed

Conditions: Heart Valve Diseases

Treatments: Device: biological heart valve prosthesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00377871

2005-218/2-14

Details and patient eligibility

About

Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in different hemodynamic and biomechanical parameters.

The study will investigate turbulence, flow and aortic root movement in a stentless bioprosthesis and compare it to a stented bioprosthesis.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 65 years old
• Submitted for aortic valve surgery
• No coronary surgery other than LIMA to LAD

Exclusion criteria

• Stentless valve implantation not possible
• Contraindications for MRI scan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

1

Active Comparator group

Description:

Valve design 1

Treatment:

Device: biological heart valve prosthesis

2

Active Comparator group

Description:

Valve design 2

Treatment:

Device: biological heart valve prosthesis

Control

No Intervention group

Description:

Healthy control