Aortic Valve InsufficiencyNCT00475267
Aortic Valve Replacement With Trifecta(TM)
A study testing Trifecta aortic heart valve in people with Aortic Valve Insufficiency and Regurgitation, Aortic Valve, run by Abbott Medical Devices at 5 sites in Canada.
Trial summary
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve. 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
- How many people
- 203 participants
- Where
- 5 sitesCanada
- Study dates
- May 2007to Jan 2012
- 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
- Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
- Legal age.
- Signed informed consent prior to surgery.
- Willing to complete all follow-up requirements.
Who cannot join
- Pregnant or nursing women.
- Have already had a valve replaced other than the aortic valve.
- Needs another valve replaced.
- Cannot return for required follow-up visits.
- Have active endocarditis.
- Acute preoperative neurological event (such as a stroke).
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- Renal dialysis.
- History of substance abuse within one year, or a prison inmate.
- Participating in another study.
- Life expectancy less than two years.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hôpital Laval
Québec, Quebec, GN 4G5
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
University of British Columbia, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: An Observational, Prospective Evaluation of the Trifecta Valve
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
Read the detailed description
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
- 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
Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize patient NYHA functional classification status.
Measured: At required follow-up intervals
Characterize the hemodynamic performance of the valve.
Measured: At required follow-up intervals
Establish adverse event rates.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2010
- Study completionJan 2012
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hartzell Schaff, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475267
- Sponsor's protocol ID
- CS0601
- Status last verified
- Feb 2019
- First submitted
- 16 May 2007
- 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
- NCT00475267
- Acronym / sponsor ID
- CS0601
- 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
- 203 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 May 2007 (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.
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
Detailed description
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
- Legal age.
- Signed informed consent prior to surgery.
- Willing to complete all follow-up requirements.
Key exclusion criteria (10 listed)
- Pregnant or nursing women.
- Have already had a valve replaced other than the aortic valve.
- Needs another valve replaced.
- Cannot return for required follow-up visits.
- Have active endocarditis.
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 valveIntended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve. | Device | – |
Primary outcome
Characterize patient NYHA functional classification status.
Time frame: At required follow-up intervals
Characterize the hemodynamic performance of the valve.
Time frame: At required follow-up intervals
Establish adverse event rates.
Time frame: Ongoing
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.
Hartzell Schaff, MD principal investigator
Mayo Clinic
5 sites in 1 country: 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 5 sites in Canada.
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 10 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 5 sites in Canada. 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?
Characterize patient NYHA functional classification status. (time frame: At required follow-up intervals). 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.