Heart Valve DiseasesNCT00377871
Hemodynamic Performance in Stentless Heart Valves
A study testing biological heart valve prosthesis in people with Heart Valve Diseases, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- biological heart valve prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- May 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Over 65 years old
- Submitted for aortic valve surgery
- No coronary surgery other than LIMA to LAD
Who cannot join
- Stentless valve implantation not possible
- Contraindications for MRI scan
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
Aarhus N, 8200
About this study
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.
- Conditions
- Heart Valve Diseases
- Being tested
- biological heart valve prosthesis
- Keywords
- Stentless, Biological, aortic, heart, valve, prosthesis, artificial
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological heart valve prosthesisDevice
Two heart valve designs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Valve design 1 Receives: Device: biological heart valve prosthesis |
| 2 | Active comparator | Valve design 2 Receives: Device: biological heart valve prosthesis |
| Control | No intervention | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
turbulence
Measured: jan 2010
flow dynamics
Measured: jan 2010
aortic root dynamics
Measured: jan 2010
Effective orifice area
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startMay 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, LivaNova, Abbott Medical Devices, Raimond and Dagmar Ringgård-Bohn's Foundation, Carl og Ellen Hertz´ Legat, Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond, Jens Anker Andersen Fonden
- Responsible party
- Sponsor
- Investigators
- Jonas A Funder, MD, Principal investigator, Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377871
- Sponsor's protocol ID
- 2005-218/2-14
- Status last verified
- Feb 2008
- First submitted
- 18 Sep 2006
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Performance in Stentless Heart Valves
- ClinicalTrials.gov ID
- NCT00377871
- Acronym / sponsor ID
- 2005-218/2-14
- Conditions
- Heart Valve Diseases
- Keywords
- Stentless, Biological, aortic, heart, valve, prosthesis, artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, LivaNova, Abbott Medical Devices, Raimond and Dagmar Ringgård-Bohn's Foundation, Carl og Ellen Hertz´ Legat, Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond, Jens Anker Andersen Fonden
- Study start
- May 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: biological heart valve prosthesisValve design 1 |
| 2 | Active comparator | Device: biological heart valve prosthesisValve design 2 |
| Control | No intervention | –Healthy control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Over 65 years old
- Submitted for aortic valve surgery
- No coronary surgery other than LIMA to LAD
Key exclusion criteria (2 listed)
- Stentless valve implantation not possible
- Contraindications for MRI scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological heart valve prosthesisTwo heart valve designs | Device | 1, 2 |
Primary outcome
turbulence
Time frame: jan 2010
flow dynamics
Time frame: jan 2010
aortic root dynamics
Time frame: jan 2010
Effective orifice area
Time frame: 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Related trials for Heart Valve Diseases
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease
Active, not recruiting
TRISCEND JAPAN Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas A Funder, MD principal investigator
Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological heart valve prosthesis in people with Heart Valve Diseases, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
turbulence (time frame: jan 2010). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015; AzTrials last refreshed its copy on 29 Oct 2026.