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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.
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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
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The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| St. Jude Medical (SJM) Conventional | Other | St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff |
|
| St. Jude Medical (SJM) Silzone | Other | St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Mechanical Heart Valve | Device | Both arms used market released mechanical heart valves in accordance with approved labeling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Heart Group | Orlando | Florida | 32803 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10224570 | Background | 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. | |
| 15464329 | Result | Davila-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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SJM Conventional | SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling |
| FG001 | SJM Silzone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Boston |
| Massachusetts |
| 02114 |
| United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Sisters of Providence Health System | Portland | Oregon | 97225 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| LDS Hospital | Salt Lake City | Utah | 84103 | United States |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| University of British Columbia | Vancouver | British Columbia | Canada |
| Hôpital G. Et R. Laënnec | Nantes | France |
| Deutches Herzzentrum Berlin | Berlin | Germany |
| Fond Ne Centro S. Raffaele | Milan | Italy |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Hospital 12 de Octubre | Madrid | Spain |
| Inselspital | Bern | CH-3010 | Switzerland |
| Hopital Regional-Service de Cardiologie | Sion | Switzerland |
| 11899956 | Result | Schaff 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. |
| 11603594 | Result | Englberger 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. |
| 16275007 | Result | Englberger 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. |
SJM Masters Series Mechanical Heart Valve with Silzone Coating Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling |
| COMPLETED |
|
| NOT COMPLETED |
|
1 subject age is missing
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| ID | Title | Description |
|---|---|---|
| BG000 | SJM Conventional | SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling |
| BG001 | SJM Silzone | SJM Masters Series Mechanical Heart Valve with Silzone Coating Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | We are missing 1 person's age in the Conventional group which would make the total 404 | Number | participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | subjects randomized into the study | Posted | Number | participants | 1 year |
|
|
|
12 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events for the Conventional Group | These patients received a conventional heart valve. | 194 | 404 | 124 | 404 | ||
| EG001 | Adverse Events for the Silzone™ Group | These patients received the Silzone™ treated heart valve. | 261 | 403 | 118 | 403 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Explant due to PV (para-valvular) leak | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| All reported explants | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| All reported explants/repairs | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| Major PV (Para-Valvular) leak | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| Stroke/RIND | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| All Cause Mortality | Cardiac disorders | endocarditis | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confirmed TE | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| Confirmed TE without TIA | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| Confimred TE Stroke | Cardiac disorders | endocarditis | Systematic Assessment |
| |
| Endocarditis | Cardiac disorders | endocarditis | Systematic Assessment |
|
This study was terminated early. No final report was created.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi Hinrichs, VP of Clinical Study Management, St. Jude Medical | St.Jude Medical | hhinrichs@sjm.com |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|