Heart Valve DiseasesNCT01514162
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
A study testing Trifecta valve in people with Heart Valve Diseases, run by Abbott Medical Devices at 6 sites in United States.
Trial summary
To further evaluate the long term 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
- Heart Valve Diseases
- What is being tested?
- Trifecta valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2012to Oct 2014
- 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
- Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
- Subject met eligibility criteria of IDE study
- Subject agrees to complete study follow-up visits
- Subject provides written informed consent
Who cannot join
- Subject currently participating in another device or drug study
- Subject unable or unwilling to return for study follow-up visits
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mission Hospital
Asheville, North Carolina, 28801
Abbott Northwestern Hospital Cardiac Surgical Associates
Minneapolis, Minnesota, 55407
Intermountain Heart & Lung Surgical Associates
Murray, Utah, 84157
Vanderbilt Heart Institute
Nashville, Tennessee, 37232
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
About this study
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
Read the detailed description
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.
- Conditions
- Heart Valve Diseases
- Being tested
- Trifecta valve
- Keywords
- Trifecta Valve
- 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.
Trifecta valveDevice
surgical replacement of aortic valve
| Study group | Role | What they receive |
|---|---|---|
| Trifecta Valve Group | Experimental | Subjects implanted with a Trifecta valve. Receives: Device: Trifecta valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Adverse Event Incidence
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: 5 years
Secondary outcomes (2)
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: 5 years
Report 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: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2014
- Study completionOct 2014
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 Heart Valve DiseasesStudies 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
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514162
- Sponsor's protocol ID
- 1003
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2012
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
- ClinicalTrials.gov ID
- NCT01514162
- Acronym / sponsor ID
- 1003
- Conditions
- Heart Valve Diseases
- Keywords
- Trifecta Valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
Detailed description
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.
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 Group | Experimental | Device: Trifecta valveSubjects implanted with a Trifecta 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)
- Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
- Subject met eligibility criteria of IDE study
- Subject agrees to complete study follow-up visits
- Subject provides written informed consent
Key exclusion criteria (2 listed)
- Subject currently participating in another device or drug study
- Subject unable or unwilling to return for study follow-up visits
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 valvesurgical replacement of aortic valve | Device | Trifecta Valve Group |
Primary outcome
Late Adverse Event Incidence
Time frame: 5 years
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]
2 secondary outcomes
Characterize Patient NYHA Functional Classification Status
Time frame: 5 years
Report the Hemodynamic Performance of the Valve
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifecta valve in people with Heart Valve Diseases, run by Abbott Medical Devices at 6 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 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 15 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 6 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 31 May 2017). 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 Incidence (time frame: 5 years). 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 15 Feb 2019.