Hemodynamic Performance in Stentless Heart Valves

Not Applicable

Completed

• Conditions: Heart Valve Diseases
• Interventions: Device: biological heart valve prosthesis

• Registration Number: NCT00377871
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-18
• Study First Posted: 2006-09-19
• Study Start: 2007-05
• Status Verified: 2008-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2015-05-31
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	biological heart valve prosthesis	Valve design 2
1	biological heart valve prosthesis	Valve design 1

Primary Outcome Measures

Name	Time	Method
turbulence	jan 2010
Effective orifice area	2010
aortic root dynamics	jan 2010
flow dynamics	jan 2010

Trial Locations

Locations (1)

Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus; 🇩🇰 Aarhus N, Denmark