Trial Outcomes & Findings for CryoValve SG Pulmonary Human Heart Valve Post Clearance Study (NCT NCT01092442)
NCT ID: NCT01092442
Last Updated: 2016-10-06
Results Overview
Peak Pulmonary Gradient Mean Pulmonary Gradient
Recruitment status
COMPLETED
Target enrollment
140 participants
Primary outcome timeframe
Most Recent follow-up (average of 3-6 years post implant)
Results posted on
2016-10-06
Participant Flow
Participant milestones
| Measure |
Retrospective Patients
Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
|
Prospective Patients
Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
60
|
|
Overall Study
COMPLETED
|
80
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
Baseline characteristics by cohort
| Measure |
Retrospective Patients
n=80 Participants
Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
|
Prospective Patients
n=60 Participants
Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
66 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
15.8 years
STANDARD_DEVIATION 14.1 • n=93 Participants
|
26.2 years
STANDARD_DEVIATION 21.1 • n=4 Participants
|
20.2 years
STANDARD_DEVIATION 18.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=93 Participants
|
60 participants
n=4 Participants
|
140 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Most Recent follow-up (average of 3-6 years post implant)Population: The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.
Peak Pulmonary Gradient Mean Pulmonary Gradient
Outcome measures
| Measure |
Retrospective Ross
n=25 Participants
|
Prospective Ross
n=39 Participants
|
Retrospective Right Ventricular Outflow Tract (RVOT)
n=47 Participants
|
Prospective RVOT
n=19 Participants
|
|---|---|---|---|---|
|
Hemodynamic Performance
Peak Pulmonary Gradient
|
22.2 mmHg
Standard Deviation 16.0
|
13.5 mmHg
Standard Deviation 10.9
|
21.2 mmHg
Standard Deviation 11.4
|
21.9 mmHg
Standard Deviation 12.1
|
|
Hemodynamic Performance
Mean Pulmonary Gradient
|
12.1 mmHg
Standard Deviation 8.3
|
7.5 mmHg
Standard Deviation 5.7
|
12.3 mmHg
Standard Deviation 6.5
|
11.7 mmHg
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: Most Recent Follow-up (average of 4 to 6 years post implant)Population: The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.
Pulmonary Insufficiency Grade
Outcome measures
| Measure |
Retrospective Ross
n=27 Participants
|
Prospective Ross
n=39 Participants
|
Retrospective Right Ventricular Outflow Tract (RVOT)
n=48 Participants
|
Prospective RVOT
n=19 Participants
|
|---|---|---|---|---|
|
Hemodynamic Performance
Severe
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Hemodynamic Performance
None
|
6 participants
|
12 participants
|
8 participants
|
3 participants
|
|
Hemodynamic Performance
Trivial
|
6 participants
|
18 participants
|
14 participants
|
13 participants
|
|
Hemodynamic Performance
Mild
|
10 participants
|
6 participants
|
12 participants
|
2 participants
|
|
Hemodynamic Performance
Moderate
|
2 participants
|
1 participants
|
10 participants
|
1 participants
|
|
Hemodynamic Performance
Moderate-Severe
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Since Implant of the Valve to a Maximum of 13.0 yearsEvaluation of the following adverse events * Mortality (all cause and valve-related) * Reoperation/reintervention * Explant * Endocarditis * Structural valve deterioration (defined as \>40 mmHg peak pulmonary gradient or \>30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency) * Thrombosis * Thromboembolism (pulmonary embolism) * Non-structural dysfunction * Perivalvular leak * Bleeding * Hemolysis * Calcification
Outcome measures
| Measure |
Retrospective Ross
n=68 Participants
|
Prospective Ross
n=72 Participants
|
Retrospective Right Ventricular Outflow Tract (RVOT)
|
Prospective RVOT
|
|---|---|---|---|---|
|
Safety Assessment
10-Year Freedom from Mortality
|
84 percentage of patients
|
97 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Non-structural Dysfunction
|
100 percentage of patients
|
100 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Perivalvular Leak
|
100 percentage of patients
|
100 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Thrombosis
|
100 percentage of patients
|
100 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Thromboembolism
|
100 percentage of patients
|
100 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Valve-Related Mortality
|
100 percentage of patients
|
100 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Reoperation/Reintervention
|
100 percentage of patients
|
81 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Explant
|
100 percentage of patients
|
88 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Endocarditis
|
100 percentage of patients
|
96 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from SVD
|
74 percentage of patients
|
52 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Bleeding
|
96 percentage of patients
|
96 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Hemolysis
|
100 percentage of patients
|
100 percentage of patients
|
—
|
—
|
|
Safety Assessment
10-Year Freedom from Calcification
|
80 percentage of patients
|
63 percentage of patients
|
—
|
—
|
Adverse Events
Ross Patients
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
RVOT Reconstruction Patients
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ross Patients
n=68 participants at risk
Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
|
RVOT Reconstruction Patients
n=72 participants at risk
Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
|
|---|---|---|
|
Cardiac disorders
Mortality
|
7.4%
5/68 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
2.8%
2/72 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
|
Cardiac disorders
Explant
|
0.00%
0/68 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
5.6%
4/72 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
|
Cardiac disorders
Reoperation/Reintervention
|
0.00%
0/68 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
9.7%
7/72 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
|
Cardiac disorders
Endocarditis
|
0.00%
0/68 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
2.8%
2/72 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
|
Cardiac disorders
Bleeding
|
1.5%
1/68 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
2.8%
2/72 • Since Implant of the Valve to a Maximum of 13 years
Other Adverse Events were not collected
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can not publish any results or data arising from the study except with the institution's approval and sponsor's written consent.
- Publication restrictions are in place
Restriction type: OTHER