Aortic Valve InsufficiencyNCT00727181
An Observational, Prospective Evaluation of the Trifecta™ Valve
A study testing Trifecta aortic heart valve in people with Aortic Valve Insufficiency and Regurgitation, Aortic Valve, run by Abbott Medical Devices at 4 sites in 3 countries.
Trial summary
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- What is being tested?
- Trifecta aortic heart valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Nov 2007to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires aortic valve replacement. (Note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study).
- Patient is legal age in host country.
- Patient (or legal guardian) has given written informed consent for participation prior to surgery.
- Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.
Who cannot join
- Patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery).
- Patient already has a prosthetic valve(s) at a site other than the aortic valve.
- Patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve.
- Patient has an inability or is unwilling to return for the required follow-up visits.
- Patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment).
- Patient has had an acute preoperative neurological event defined as patient has not returned to baseline or has not stabilized 30 days prior to the planned valve implantation surgery.
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- Patient is undergoing renal dialysis.
- Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
- Patient is currently participating in the study of an investigational drug or device, or the patient was previously participating in an investigational drug study and has not completed a 30-day wash out period.
- Patient had the Trifecta valve implanted as part of this study, but then had the device explanted.
- Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
- Patient has a life expectancy less than two years.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Universitat Herzzentrum Leipzig GmbH
Leipzig, 04289
Deutsches Herzzentrum München
München, 80636
About this study
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.
Read the detailed description
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Being tested
- Trifecta aortic heart valve
- Keywords
- aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis, aortic valve regurgitation
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifecta aortic heart valveDevice
Replacement of a diseased, damaged, or malfunctioning aortic heart valve
| Study group | Role | What they receive |
|---|---|---|
| Trifecta Valve | Other | The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. Receives: Device: Trifecta aortic heart valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize patient NYHA functional classification status
Measured: CE labelling
To characterize the hemodynamic performance of the valve, as per echocardiography
Measured: CE labelling
Safety outcomes
Measured: CE labelling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Friedrich W Mohr, MD, Principal investigator, Universitat Herzzentrum Leipzig GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727181
- Sponsor's protocol ID
- CS05002TV
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2008
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective Evaluation of the Trifecta™ Valve
- ClinicalTrials.gov ID
- NCT00727181
- Acronym / sponsor ID
- CS05002TV
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Keywords
- aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Aug 2008 (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.
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.
Detailed description
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trifecta Valve | Other | Device: Trifecta aortic heart valveThe Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient requires aortic valve replacement. (Note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study).
- Patient is legal age in host country.
- Patient (or legal guardian) has given written informed consent for participation prior to surgery.
- Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.
Key exclusion criteria (12 listed)
- Patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery).
- Patient already has a prosthetic valve(s) at a site other than the aortic valve.
- Patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve.
- Patient has an inability or is unwilling to return for the required follow-up visits.
- Patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment).
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 |
|---|---|---|
| Trifecta aortic heart valveReplacement of a diseased, damaged, or malfunctioning aortic heart valve | Device | Trifecta Valve |
Primary outcome
To characterize patient NYHA functional classification status
Time frame: CE labelling
To characterize the hemodynamic performance of the valve, as per echocardiography
Time frame: CE labelling
Safety outcomes
Time frame: CE labelling
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 4 Feb 2019.
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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.
Friedrich W Mohr, MD principal investigator
Universitat Herzzentrum Leipzig GmbH
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifecta aortic heart valve in people with Aortic Valve Insufficiency and Regurgitation, Aortic Valve, run by Abbott Medical Devices at 4 sites in 3 countries.
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 4 inclusion and 12 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, France, Netherlands. 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?
To characterize patient NYHA functional classification status (time frame: CE labelling). The study lists 3 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 4 Feb 2019.