Hemodynamic Performance in Stentless Heart Valves

Heart Valve Diseases Clinical Trial

Official title:

Hemodynamic Performance in Stentless Heart Valves

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377871
• Other study ID #: 2005-218/2-14
• Status: Completed
• Phase: N/A
• First received: September 18, 2006
• Last updated: May 31, 2015
• Start date: May 2007
• Est. completion date: January 2010

Study information

• Verified date: February 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• biological heart valve prosthesis
Two heart valve designs

Locations

Country	Name	City	State
Denmark	Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus	Aarhus N

Sponsors (8)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Carl og Ellen Hertz´ Legat, Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond, Jens Anker Andersen Fonden, LivaNova, Raimond and Dagmar Ringgård-Bohn's Foundation, St. Jude Medical

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	turbulence		jan 2010	No
Primary	flow dynamics		jan 2010	No
Primary	aortic root dynamics		jan 2010	No
Primary	Effective orifice area		2010	No