NCT00377871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 2, 2015

Status Verified

February 1, 2008

Enrollment Period

2.7 years

First QC Date

September 18, 2006

Last Update Submit

May 31, 2015

Conditions

Heart Valve Diseases

Keywords

StentlessBiologicalaorticheartvalveprosthesisartificial

Outcome Measures

Primary Outcomes (4)

  • turbulence

    jan 2010

  • flow dynamics

    jan 2010

  • aortic root dynamics

    jan 2010

  • Effective orifice area

    2010

Study Arms (3)

1

ACTIVE COMPARATOR

Valve design 1

Device: biological heart valve prosthesis

2

ACTIVE COMPARATOR

Valve design 2

Device: biological heart valve prosthesis

Control

NO INTERVENTION

Healthy control

Interventions

biological heart valve prosthesisDEVICE

Two heart valve designs

12

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Stentless valve implantation not possible
  • Contraindications for MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jonas A Funder, MD

    Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

May 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 2, 2015

Record last verified: 2008-02

Locations

DK(1)