Aortic Valve InsufficiencyNCT00475709
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 18 sites in United States.
Trial summary
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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,022 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2007to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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).
Show all 10Show fewer
- 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
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Mission Hospitals
Asheville, North Carolina, 28801
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital
Los Angeles, California, 90033
Loyola University Medical Center
Maywood, Illinois, 60153
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53201
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Intermountain Medical Center
Murray, Utah, 84157
Vanderbilt Medical Center
Nashville, Tennessee, 37212
NYU Medical Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
Sarasota Memorial Hospital/Clinical Research Center
Sarasota, Florida, 34239
Main Line Health Heart Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: An Observational, Prospective Evaluation of the Trifecta Valve
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
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
| Study group | Role | What they receive |
|---|---|---|
| Trifecta Aortic Heart Valve | Experimental | All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve. Receives: Device: Trifecta Aortic Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Adverse Event Rates
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.
Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]
Measured: Events occurring greater than or equal to 31 days post-implant.
Characterize Patient NYHA Functional Classification Status.
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.
Measured: 1 year
Characterize the Hemodynamic Performance of the Valve.
Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.
Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.
Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.
Measured: 1 year
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 startJun 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 1,022 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
- NCT00475709
- Sponsor's protocol ID
- CS0501
- Status last verified
- Feb 2019
- First submitted
- 16 May 2007
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 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
- NCT00475709
- Acronym / sponsor ID
- CS0501
- 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
- 1,022 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 11 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trifecta Aortic Heart Valve | Experimental | Device: Trifecta Aortic Heart ValveAll subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve. |
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 ValveSurgical replacement of the aortic valve with the Trifecta Aortic Heart Valve. | Device | Trifecta Aortic Heart Valve |
Primary outcome
Late Adverse Event Rates
Time frame: Events occurring greater than or equal to 31 days post-implant.
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]
Characterize Patient NYHA Functional Classification Status.
Time frame: 1 year
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.
Characterize the Hemodynamic Performance of the Valve.
Time frame: 1 year
Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
18 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 18 sites in United States.
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 19 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 18 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Late Adverse Event Rates (time frame: Events occurring greater than or equal to 31 days post-implant.). 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 19 Feb 2019.