Mitral Valve or Aortic Valve Replacement
Conditions
Keywords
Heart Valve Replacement, Perimount 2900, China, Perimount 6900P
Brief summary
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.
Interventions
DEVICEPerimount 2900/6900 Heart Valve
This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit.
Sponsors
Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China * The patients agree to join the study and sign the ICF
Exclusion criteria
* No specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | 7-15 years after heart valve replacement surgery (during 2001-2007) | This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Patients Enrolled in Study The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set). | 225 |
| Total | 225 |
Baseline characteristics
| Characteristic | All Patients Enrolled in Study |
|---|---|
| Age, Continuous | 63 years |
| Etiology of subjects Degenerated | 51 participants |
| Etiology of subjects Endocardititis | 6 participants |
| Etiology of subjects Ischemic | 18 participants |
| Etiology of subjects Miscellaneous | 26 participants |
| Etiology of subjects Rheumatic | 124 participants |
| Preoperative Classification of NYHA assessment Class I | 5 participants |
| Preoperative Classification of NYHA assessment Class II | 79 participants |
| Preoperative Classification of NYHA assessment Class III | 96 participants |
| Preoperative Classification of NYHA assessment Class IV | 31 participants |
| Preoperative Classification of NYHA assessment Not Known | 14 participants |
| Sex: Female, Male Female | 119 Participants |
| Sex: Female, Male Male | 106 Participants |
| The concomitant surgery Coronary Artery Bypass Grafting | 41 participants |
| The concomitant surgery Left Atrial Reduction | 5 participants |
| The concomitant surgery Radiofrequency Ablation | 4 participants |
| The concomitant surgery Tricuspid valvuloplasty | 75 participants |
| The numbers of valves implanted simultaneously Double Valves Replacement | 48 participants |
| The numbers of valves implanted simultaneously Single Valve Replacement | 174 participants |
| The numbers of valves implanted simultaneously Triple Valves Replacement | 3 participants |
| The time for Extracorporeal Circulation and Cross Clamp in surgery Time for cross clamp | 89.5 minutes STANDARD_DEVIATION 40.2 |
| The time for Extracorporeal Circulation and Cross Clamp in surgery Time for Extracorporeal Circulation | 137.9 minutes STANDARD_DEVIATION 66.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 54 | 27 / 139 | 2 / 32 |
| serious Total, serious adverse events | 12 / 54 | 60 / 139 | 22 / 32 |
Outcome results
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
Time frame: 7-15 years after heart valve replacement surgery (during 2001-2007)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| One-arm Group Included All Enrolled Subjects | The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | Freedom from SVD at 5 years | 100 Percentage of all subjects |
| One-arm Group Included All Enrolled Subjects | The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | Freedom from SVD at 10 years | 54.54 Percentage of all subjects |
| One-arm Group Included All Enrolled Subjects | The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | Freedom from SVD at 15 years | 26.51 Percentage of all subjects |
| One-arm Group Included All Enrolled Subjects | The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | Overall survival rate at 5 years | 81.33 Percentage of all subjects |
| One-arm Group Included All Enrolled Subjects | The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | Overall survival rate at 10 years | 62.41 Percentage of all subjects |
| One-arm Group Included All Enrolled Subjects | The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography | Overall survival rate at 15 years | 51.63 Percentage of all subjects |