Aortic Valve DiseaseAVERTNCT00590889
Artificial Valve Endocarditis Reduction Trial
A study testing Artificial Mechanical Heart Valve in people with Aortic Valve Disease and Mitral Valve Disease, run by Abbott Medical Devices at 16 sites in 8 countries.
Trial summary
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- What is being tested?
- Artificial Mechanical Heart Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 807 participants
- Where
- 16 sitesin 8 countries
- Study dates
- Jul 1998to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient requires an isolated mitral, isolated aortic, or double (aortic and mitral) valve replacement
- The patient is a candidate to receive an SJM (St. Jude Medical) Masters Series valve(s) with either the conventional cuff or the cuff with Silzone coating
- The patient (or legal guardian) has signed a study-specific consent form agreeing to the randomization, data collection, and follow-up requirements
Who cannot join
- The patient has a medical condition which contraindicates implantation of the SJM Masters Series with Silzone coating
- The patient already has a prosthetic valve other than the valve being replaced at this time
- The patient requires a tricuspid valve replacement
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Texas Heart Institute
Houston, Texas, 77030
Florida Heart Group
Orlando, Florida, 32803
Sisters of Providence Health System
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55902
LDS Hospital
Salt Lake City, Utah, 84103
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta
University of British Columbia
Vancouver, British Columbia
Switzerland2 sites
Inselspital
Bern, CH-3010
Hopital Regional-Service de Cardiologie
Sion
About this study
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
Read the detailed description
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis. The null and alternative hypotheses of this study are:
- Ho: Patients receiving SJM Masters Series valves with Silzone coating will have an equal incidence of PVE when compared to those receiving the conventional cuff.
- Ha: Patients receiving SJM Masters Series valves with Silzone coating will have a reduced incidence of PVE when compared to those receiving the conventional cuff.
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Being tested
- Artificial Mechanical Heart Valve
- Keywords
- artificial heart valve, mitral heart valve, aortic heart valve, endocarditis, Aortic valve disease requiring replacement, Mitral valve disease requiring replacement
- Medical subject headings
- Aortic Valve Disease, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Mechanical Heart ValveDevice
Both arms used market released mechanical heart valves in accordance with approved labeling
| Study group | Role | What they receive |
|---|---|---|
| St. Jude Medical (SJM) Conventional | Other | St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff Receives: Device: Artificial Mechanical Heart Valve |
| St. Jude Medical (SJM) Silzone | Other | St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating Receives: Device: Artificial Mechanical Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.
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 posted11 Jan 2008 (estimated)
- Study startJul 1998
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: A post-PMA begun in 1998; enrollment halted in 2000 due to an anomaly in one study arm. The protocol required annual study visits after 2000.
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590889
- Sponsor's protocol ID
- 979
- Acronym
- AVERT
- Status last verified
- Feb 2019
- First submitted
- 26 Dec 2007
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schaff H, Carrel T, Steckelberg JM, Grunkemeier GL, Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis. 1999 Mar;8(2):131-9.
PubMed 10224570Davila-Roman VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, Carrel TP, Schaff HV; Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol. 2004 Oct 6;44(7):1467-72. doi: 10.1016/j.jacc.2003.12.060.
PubMed 15464329Schaff HV, Carrel TP, Jamieson WR, Jones KW, Rufilanchas JJ, Cooley DA, Hetzer R, Stumpe F, Duveau D, Moseley P, van Boven WJ, Grunkemeier GL, Kennard ED, Holubkov R; Artificial Valve Endocarditis Reduction Trial. Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg. 2002 Mar;73(3):785-92. doi: 10.1016/s0003-4975(01)03442-7.
PubMed 11899956Englberger L, Carrel T, Schaff HV, Kennard ED, Holubkov R; AVERT Investigators. Differences in heart valve procedures between North American and European centers: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). J Heart Valve Dis. 2001 Sep;10(5):562-71.
PubMed 11603594Englberger L, Schaff HV, Jamieson WR, Kennard ED, Im KA, Holubkov R, Carrel TP; AVERT Investigators. Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). Eur J Cardiothorac Surg. 2005 Dec;28(6):838-43. doi: 10.1016/j.ejcts.2005.09.014. Epub 2005 Nov 7.
PubMed 16275007
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Valve Endocarditis Reduction Trial
- ClinicalTrials.gov ID
- NCT00590889
- Acronym / sponsor ID
- AVERT / 979
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Keywords
- artificial heart valve, mitral heart valve, aortic heart valve, endocarditis, Aortic valve disease requiring replacement, Mitral valve disease requiring replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A post-PMA begun in 1998; enrollment halted in 2000 due to an anomaly in one study arm. The protocol required annual study visits after 2000.
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Study start
- Jul 1998
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 22 Dec 2015
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 investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
Detailed description
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis. The null and alternative hypotheses of this study are:
- Ho: Patients receiving SJM Masters Series valves with Silzone coating will have an equal incidence of PVE when compared to those receiving the conventional cuff.
- Ha: Patients receiving SJM Masters Series valves with Silzone coating will have a reduced incidence of PVE when compared to those receiving the conventional cuff.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| St. Jude Medical (SJM) Conventional | Other | Device: Artificial Mechanical Heart ValveSt. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff |
| St. Jude Medical (SJM) Silzone | Other | Device: Artificial Mechanical Heart ValveSt. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient requires an isolated mitral, isolated aortic, or double (aortic and mitral) valve replacement
- The patient is a candidate to receive an SJM (St. Jude Medical) Masters Series valve(s) with either the conventional cuff or the cuff with Silzone coating
- The patient (or legal guardian) has signed a study-specific consent form agreeing to the randomization, data collection, and follow-up requirements
Key exclusion criteria (3 listed)
- The patient has a medical condition which contraindicates implantation of the SJM Masters Series with Silzone coating
- The patient already has a prosthetic valve other than the valve being replaced at this time
- The patient requires a tricuspid valve replacement
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 |
|---|---|---|
| Artificial Mechanical Heart ValveBoth arms used market released mechanical heart valves in accordance with approved labeling | Device | St. Jude Medical (SJM) Conventional, St. Jude Medical (SJM) Silzone |
Primary outcome
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
Time frame: 1 year
Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10224570Schaff H, Carrel T, Steckelberg JM, Grunkemeier GL, Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis. 1999 Mar;8(2):131-9.
- Results publication: PubMed 15464329Davila-Roman VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, Carrel TP, Schaff HV; Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol. 2004 Oct 6;44(7):1467-72. doi: 10.1016/j.jacc.2003.12.060.
- Results publication: PubMed 11899956Schaff HV, Carrel TP, Jamieson WR, Jones KW, Rufilanchas JJ, Cooley DA, Hetzer R, Stumpe F, Duveau D, Moseley P, van Boven WJ, Grunkemeier GL, Kennard ED, Holubkov R; Artificial Valve Endocarditis Reduction Trial. Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg. 2002 Mar;73(3):785-92. doi: 10.1016/s0003-4975(01)03442-7.
- Results publication: PubMed 11603594Englberger L, Carrel T, Schaff HV, Kennard ED, Holubkov R; AVERT Investigators. Differences in heart valve procedures between North American and European centers: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). J Heart Valve Dis. 2001 Sep;10(5):562-71.
- Results publication: PubMed 16275007Englberger L, Schaff HV, Jamieson WR, Kennard ED, Im KA, Holubkov R, Carrel TP; AVERT Investigators. Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). Eur J Cardiothorac Surg. 2005 Dec;28(6):838-43. doi: 10.1016/j.ejcts.2005.09.014. Epub 2005 Nov 7.
Related trials for Aortic Valve Disease
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
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.
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Mechanical Heart Valve in people with Aortic Valve Disease and Mitral Valve Disease, run by Abbott Medical Devices at 16 sites in 8 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 27 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 16 sites in United States, Canada, Switzerland, France, Germany and 3 more countries. 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 22 Dec 2015). 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?
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590889, which also lists 5 linked publications.
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 27 Feb 2019.