Trial Outcomes & Findings for A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007 (NCT NCT02381678)
NCT ID: NCT02381678
Last Updated: 2016-10-17
Results Overview
This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography
Recruitment status
COMPLETED
Target enrollment
225 participants
Primary outcome timeframe
7-15 years after heart valve replacement surgery (during 2001-2007)
Results posted on
2016-10-17
Participant Flow
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.
Participant milestones
| Measure |
Age Group Under 60 Years Old
54 subjects implanted Perimount Heart Valve when the age was under 60.
|
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)
|
Age Group Above 70 Years Old
32 subjects implanted Perimount Heart Valve when the age was above 70
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
139
|
32
|
|
Overall Study
COMPLETED
|
54
|
139
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
Baseline characteristics by cohort
| Measure |
All Patients Enrolled in Study
n=225 Participants
The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set).
|
|---|---|
|
The numbers of valves implanted simultaneously
Single Valve Replacement
|
174 participants
n=5 Participants
|
|
The numbers of valves implanted simultaneously
Double Valves Replacement
|
48 participants
n=5 Participants
|
|
The numbers of valves implanted simultaneously
Triple Valves Replacement
|
3 participants
n=5 Participants
|
|
The concomitant surgery
Coronary Artery Bypass Grafting
|
41 participants
n=5 Participants
|
|
The concomitant surgery
Left Atrial Reduction
|
5 participants
n=5 Participants
|
|
The concomitant surgery
Tricuspid valvuloplasty
|
75 participants
n=5 Participants
|
|
The concomitant surgery
Radiofrequency Ablation
|
4 participants
n=5 Participants
|
|
The time for Extracorporeal Circulation and Cross Clamp in surgery
Time for Extracorporeal Circulation
|
137.9 minutes
STANDARD_DEVIATION 66.6 • n=5 Participants
|
|
The time for Extracorporeal Circulation and Cross Clamp in surgery
Time for cross clamp
|
89.5 minutes
STANDARD_DEVIATION 40.2 • n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
|
Etiology of subjects
Rheumatic
|
124 participants
n=5 Participants
|
|
Etiology of subjects
Degenerated
|
51 participants
n=5 Participants
|
|
Etiology of subjects
Endocardititis
|
6 participants
n=5 Participants
|
|
Etiology of subjects
Ischemic
|
18 participants
n=5 Participants
|
|
Etiology of subjects
Miscellaneous
|
26 participants
n=5 Participants
|
|
Preoperative Classification of NYHA assessment
Class I
|
5 participants
n=5 Participants
|
|
Preoperative Classification of NYHA assessment
Class II
|
79 participants
n=5 Participants
|
|
Preoperative Classification of NYHA assessment
Class III
|
96 participants
n=5 Participants
|
|
Preoperative Classification of NYHA assessment
Class IV
|
31 participants
n=5 Participants
|
|
Preoperative Classification of NYHA assessment
Not Known
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
One-arm Group Included All Enrolled Subjects
n=225 Participants
This group included total 225 enrolled participants
|
|---|---|
|
The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography
Freedom from SVD at 5 years
|
100 Percentage of all 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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Age Group Under 60 Years Old
Serious events: 12 serious events
Other events: 14 other events
Deaths: 0 deaths
Age Group Between 60 and 70 Years Old
Serious events: 60 serious events
Other events: 27 other events
Deaths: 0 deaths
Age Group Above 70 Years Old
Serious events: 22 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Age Group Under 60 Years Old
n=54 participants at risk
54 subjects implanted Perimount Heart Valve when the age was under 60.
|
Age Group Between 60 and 70 Years Old
n=139 participants at risk
139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (\>=60,\<70)
|
Age Group Above 70 Years Old
n=32 participants at risk
32 subjects implanted Perimount Heart Valve when the age was above 70
|
|---|---|---|---|
|
Cardiac disorders
Death
|
14.8%
8/54 • Number of events 8 • 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)
|
40.3%
56/139 • Number of events 56 • 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)
|
68.8%
22/32 • Number of events 22 • 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)
|
|
Cardiac disorders
Re-operation
|
7.4%
4/54 • Number of events 4 • 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)
|
2.9%
4/139 • Number of events 4 • 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)
|
0.00%
0/32 • 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)
|
Other adverse events
| Measure |
Age Group Under 60 Years Old
n=54 participants at risk
54 subjects implanted Perimount Heart Valve when the age was under 60.
|
Age Group Between 60 and 70 Years Old
n=139 participants at risk
139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (\>=60,\<70)
|
Age Group Above 70 Years Old
n=32 participants at risk
32 subjects implanted Perimount Heart Valve when the age was above 70
|
|---|---|---|---|
|
Cardiac disorders
SVD
|
25.9%
14/54 • Number of events 14 • 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)
|
19.4%
27/139 • Number of events 27 • 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)
|
6.2%
2/32 • Number of events 2 • 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)
|
Additional Information
Dr. Huiming Guo (Chief in Cardiac Surgical Department)
Guangdong General Hospital
Phone: 86-13609089789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place