Hemodynamic Performance in Stentless Heart Valves | NCT00377871

Studies
Hemodynamic Performance in Stentless Heart Valves

NCT00377871

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 2, 2015Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Heart Valve Diseases

Interventions

biological heart valve prosthesis

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Sep 18, 2006

First Submission Date that Met QC Criteria

Sep 18, 2006

First Posted Date

Sep 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2015

Last Update Posted Date

Jun 2, 2015Estimated

Name	Class
Aarhus University Hospital	OTHER
LivaNova	INDUSTRY
Abbott Medical Devices	INDUSTRY
Raimond and Dagmar Ringgård-Bohn's Foundation

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
biological heart valve prosthesis	Device	Two heart valve designs	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
turbulence		jan 2010
flow dynamics		jan 2010
aortic root dynamics		jan 2010
Effective orifice area		2010

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonas A Funder, MD	Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus		Aarhus N		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided