|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130009 S037/ PAS001 |
| Study Name |
COMPASSION Cohort
|
| Device Name |
SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of all living subjects who were enrolled under the IDE (G060242). The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
|
| Study Population |
All living subjects who were enrolled in the IDE
|
| Sample Size |
All living subjects
|
| Key Study Endpoints |
The safety and effectiveness endpoints include freedom from device- or procedure-related death or reintervention, freedom from MACCE,
functional improvement (decrease in pulmonary regurgitation, improvement in NYHA functional class, freedom from recurrent pulmonary stenosis), procedural- and device-related adverse events, stent fracture, reintervention on the THV or conduit, and death.
|
| Follow-up Visits and Length of Follow-up |
5 years
All subjects are followed at 30 days, 6 months, 12 months, and annually thereafter through 5 years post procedure
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
81 subjects were enrolled, of which 79 had an attempted implant, and 69 had a successful implant.
|
| Actual Number of Sites Enrolled |
Seven study sites were enrolled.
|
| Patient Follow-up Rate |
The follow-up rate through five years approximately 80%.
Compliance with visit assessments (e.g. NYHA classification, chest x-ray, CT angiogram, exercise testing) ranged from 55% to 86% of subjects who attended the final 5-year visit.
|
| Final Safety Findings |
Approximately 50% of subjects experienced a serious adverse event during the study duration. The most frequently observed adverse event (occurring more than 30-days post-procedure) were: arrhythmia (observed in approximately 12% of subjects), infections other than endocarditis (observed in approximately 10% of subjects), valve stenosis (observed in approximately 10% of subjects, and the catchall “other serious adverse event” category (“other” serious adverse events including but not limited to: fractures, small bowel obstruction, chest pain, and dysfunctional dialysis grafts were observed in approximately 20% of subjects).
|
| Final Effect Findings |
Approximately 73% of subjects implanted with the device and followed through 5-years showed overall functional improvement through 5-years. Approximately 84% of subjects implanted and followed-through five years remained free of recurrent pulmonary stenosis. The survival rate through five years was approximately 97% for this same population. Freedom from valve dysfunction (defined as freedom from death, surgical pulmonary valve replacement, valve frame fracture, recurrent pulmonary stenosis, moderate/sever regurgitation, or reintervention) was approximately 73% through 5 years for the same population.
|
| Study Strengths & Weaknesses |
This continued follow-up study provides longer-term data (through five years) on the safety and effectiveness of a transcatheter valve used for RVOT repair in the pulmonic position. The lack of completion of some assessments of interest including NYHA Classification, and echocardiographic imaging at the five-year study visit presents some challenges to the interpretability of longer-term effectiveness outcomes. Additionally, it should be noted that some subjects withdrew or were lost to follow-up in this study. Incomplete follow-up may also lead to biased longer-term results.
|
| Recommendations for Labeling Changes |
No. The device is no longer going to be sold or marketed
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