Aortic Valve InsufficiencyNCT00636987
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
A study testing Biocor and Biocor Supra valves in people with Aortic Valve Insufficiency and Aortic Valve Regurgitation, run by Abbott Medical Devices at 17 sites in United States.
Trial summary
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis
- What is being tested?
- Biocor and Biocor Supra valves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2007to Mar 2016
- 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 or mitral 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
- Already have had a valve replaced other than that for the scheduled replacement
- Needs another valve replaced
- Cannot return for required follow-up visits
- Have active endocarditis
- Acute preoperative neurological event (such as a stroke)
Show all 11Show fewer
- Renal dialysis
- History of substance abuse within one year or is a prison inmate
- Participating in another study
- Had the Biocor or Biocor Supra valve implanted but then the device was explanted
- Life expectancy less than five years
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Heart Group, PC
Evansville, Indiana, 47710
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana Heart Hospital
Indianapolis, Indiana, 46240
St. Luke's Hospital
Kansas City, Missouri, 64111
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Scripps Green Hospital/Scripps Clinic
La Jolla, California, 92103
USC University Hospital, Department of Cardiothoracic Surgery
Los Angeles, California, 90033
Catholic Medical Center
Manchester, New Hampshire, 03102
Saint Thomas Hospital
Nashville, Tennessee, 37205
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Sentara Norfolk General Hospital/Sentara Heart Hospital
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Valley Hospital
Ridgewood, New Jersey, 07450
HealthEast St. Joseph Hospital
Saint Paul, Minnesota, 55102
About this study
Official title: Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Read the detailed description
The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation
- Being tested
- Biocor and Biocor Supra valves
- Keywords
- aortic valve, mitral valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve regurgitation, aortic valve stenosis, mitral valve regurgitation, mitral valve stenosis
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biocor and Biocor Supra valvesDevice
Also called Heart Valve Replacement
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
| Study group | Role | What they receive |
|---|---|---|
| Implanted with Biocor or Biocor Supra Valves | Other | Not described Receives: Device: Biocor and Biocor Supra valves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of participants with Adverse Events
Measured: 5 Years
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 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.
Measured: 5 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startApr 2007
- Primary completionOct 2015
- Study completionMar 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urban Lonn, MD, PhD, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636987
- Sponsor's protocol ID
- 0505
- Status last verified
- Jan 2019
- First submitted
- 10 Mar 2008
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
- ClinicalTrials.gov ID
- NCT00636987
- Acronym / sponsor ID
- 0505
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation
- Keywords
- aortic valve, mitral valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Posted 2 Jun 2017
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 further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Detailed description
The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted with Biocor or Biocor Supra Valves | Other | Device: Biocor and Biocor Supra valves |
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 or mitral 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 (11 listed)
- Pregnant or nursing women
- Already have had a valve replaced other than that for the scheduled replacement
- 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 |
|---|---|---|
| Biocor and Biocor Supra valvesAlso: Heart Valve ReplacementReplacement for a diseased, damaged, malformed aortic or mitral heart valve | Device | Implanted with Biocor or Biocor Supra Valves |
Primary outcome
Number of Participants With Adverse Events
Time frame: 5 Years
Number of participants with Adverse Events
Characterize Patient NYHA Functional Classification Status
Time frame: 5 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: 5 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
Urban Lonn, MD, PhD study director
Abbott Medical Devices
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biocor and Biocor Supra valves in people with Aortic Valve Insufficiency and Aortic Valve Regurgitation, run by Abbott Medical Devices at 17 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 11 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 17 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 2 Jun 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?
Number of Participants With Adverse Events (time frame: 5 Years). 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.