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The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis.
This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects implanted with Perimount Heart Valve | Only one group was set for this study, including all enrolled subjects who implanted with Perimount Heart Valve during 2001 to 2007 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perimount 2900/6900 Heart Valve | Device | This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography | 7-15 years after heart valve replacement surgery (during 2001-2007) |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who had the Perimount Heart Valve (Type: 6900P and 2900) Replacement Surgery during 2001-2007 in Guangdong General Hospital in China
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| Name | Affiliation | Role |
|---|---|---|
| Huiming Guo, M.D | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Guangzhou | Guangdong | 510120 | China |
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Investigators find total 253 patients who implanted Perimount Heart Valve during 2001 to 2007 in the Guangdong General Hospital. After the contact with these patients or their relatives, 225 patients agree to join the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Age Group Under 60 Years Old | 54 subjects implanted Perimount Heart Valve when the age was under 60. |
| FG001 | Age Group Between 60 and 70 Years Old | 139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| FG002 | Age Group Above 70 Years Old | 32 subjects implanted Perimount Heart Valve when the age was above 70 |
| COMPLETED |
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| NOT COMPLETED |
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This is one-arm study, all 225 subjects included in the Full Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients Enrolled in Study | The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Etiology of subjects | Number | participants |
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| Preoperative Classification of NYHA assessment | The criteria for NYHA assessment listed below: Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bed-bound patients. | Number | participants |
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| The numbers of valves implanted simultaneously | Number | participants |
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| The concomitant surgery | Number | participants |
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| The time for Extracorporeal Circulation and Cross Clamp in surgery | Mean | Standard Deviation | minutes |
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| 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 | The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography | Posted | Number | Percentage of all subjects | 7-15 years after heart valve replacement surgery (during 2001-2007) |
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All patients implanted with Perimount Heart Valves during 2001 to 2007. And investigators collect these patients' current healthy information and report the safety and efficacy results of a 9-15 year follow-up investigation
The serious adverse events for these subjects included death and reoperation. And the adverse events mainly included SVD (structure of valve deterioration)
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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 | Age Group Under 60 Years Old | 54 subjects implanted Perimount Heart Valve when the age was under 60. | 12 | 54 | 14 | 54 | ||
| EG001 | Age Group Between 60 and 70 Years Old | 139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70) | 60 | 139 | 27 | 139 | ||
| EG002 | Age Group Above 70 Years Old | 32 subjects implanted Perimount Heart Valve when the age was above 70 | 22 | 32 | 2 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Death | Systematic Assessment |
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| Re-operation | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SVD | Cardiac disorders | SVD | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Huiming Guo (Chief in Cardiac Surgical Department) | Guangdong General Hospital | 86-13609089789 | guohuiming@vip.tom.com |
| Endocardititis |
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| Ischemic |
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| Miscellaneous |
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| Title | Measurements |
|---|
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| Class III |
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| Class IV |
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| Not Known |
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| Triple Valves Replacement |
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| Tricuspid valvuloplasty |
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| Radiofrequency Ablation |
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| Title | Measurements |
|---|---|
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| Overall survival rate at 5 years |
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| Overall survival rate at 10 years |
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| Overall survival rate at 15 years |
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