Trial Outcomes & Findings for COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV (NCT NCT00676689)
NCT ID: NCT00676689
Last Updated: 2020-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
1 year
Results posted on
2020-02-26
Participant Flow
Participant milestones
| Measure |
SAPIEN THV
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
Procedure
|
79
|
|
Overall Study
30 Day Follow-up
|
78
|
|
Overall Study
1 Year Follow-up
|
64
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
SAPIEN THV
|
|---|---|
|
Overall Study
Screen Failure
|
2
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Continuing FU
|
49
|
Baseline Characteristics
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Baseline characteristics by cohort
| Measure |
SAPIEN THV
n=79 Participants
|
|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
New York Heart Association Group
Class I/II
|
54 participants
n=5 Participants
|
|
New York Heart Association Group
Class III/IV
|
25 participants
n=5 Participants
|
|
Primary Indication
Pulmonary Stenosis
|
7 participants
n=5 Participants
|
|
Primary Indication
Pulmonary Regurgitation
|
10 participants
n=5 Participants
|
|
Primary Indication
Both
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.
Outcome measures
| Measure |
SAPIEN THV
n=69 Participants
|
|---|---|
|
Freedom From Device or Procedure Related Death or Reintervention
|
97.1 percentage of participants
Interval 88.9 to 99.3
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.
Clinical Events Committee (CEC) adjudicated.
Outcome measures
| Measure |
SAPIEN THV
n=69 Participants
|
|---|---|
|
Freedom From MACCE
|
94.1 percentage of participants
Interval 85.1 to 97.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Valve implant population. There were 2 screen failure patients and 10 patients where procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population. There were 11 additional patients for which data was not available for analysis, leaving 58 patients in this analysis.
Functional improvement at 6 months as defined by: a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.
Outcome measures
| Measure |
SAPIEN THV
n=58 Participants
|
|---|---|
|
Functional Improvement
|
51 participants
|
Adverse Events
SAPIEN THV
Serious events: 38 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SAPIEN THV
n=79 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Cardiac disorders
Angina
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Cardiac disorders
Arrhythmia
|
7.6%
6/79 • Number of events 8 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Vascular disorders
Bleeding Event
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Cardiac disorders
CHF
|
5.1%
4/79 • Number of events 11 • All events.
Site reported.
|
|
Injury, poisoning and procedural complications
Device migration
|
2.5%
2/79 • Number of events 2 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Blood and lymphatic system disorders
Electrolyte and/or CBC and platelet counts abnormal
|
2.5%
2/79 • Number of events 11 • All events.
Site reported.
|
|
Vascular disorders
Embolism: air or thrombus
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Infections and infestations
Endocarditis
|
3.8%
3/79 • Number of events 4 • All events.
Site reported.
|
|
General disorders
Fever
|
5.1%
4/79 • Number of events 4 • All events.
Site reported.
|
|
Vascular disorders
Hematoma
|
2.5%
2/79 • Number of events 2 • All events.
Site reported.
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Vascular disorders
Hemorrhage requiring transfusion
|
3.8%
3/79 • Number of events 3 • All events.
Site reported.
|
|
Vascular disorders
Hemorrhagic event
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Vascular disorders
Hypotension
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Infections and infestations
Infection (excluding endocarditis)
|
8.9%
7/79 • Number of events 12 • All events.
Site reported.
|
|
Vascular disorders
Ischemia
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Cardiac disorders
MI
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Nervous system disorders
Neurological Event (including TIA, stroke and psychomotor deficit)
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Surgical and medical procedures
Non-emergent reoperation
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Cardiac disorders
Nonstructural valve dysfunction
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Injury, poisoning and procedural complications
Pulmonary artery perforation - rupture of RVOT conduit
|
6.3%
5/79 • Number of events 5 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory complication
|
2.5%
2/79 • Number of events 2 • All events.
Site reported.
|
|
Nervous system disorders
Syncope
|
3.8%
3/79 • Number of events 3 • All events.
Site reported.
|
|
Vascular disorders
Thromboembolism
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Cardiac disorders
Valve damage or dysfunction
|
3.8%
3/79 • Number of events 3 • All events.
Site reported.
|
|
Cardiac disorders
Valve stenosis
|
7.6%
6/79 • Number of events 9 • All events.
Site reported.
|
|
General disorders
Other
|
16.5%
13/79 • Number of events 37 • All events.
Site reported.
|
Other adverse events
| Measure |
SAPIEN THV
n=79 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
4/79 • Number of events 4 • All events.
Site reported.
|
|
Cardiac disorders
Angina
|
3.8%
3/79 • Number of events 3 • All events.
Site reported.
|
|
Cardiac disorders
Arrhythmia
|
10.1%
8/79 • Number of events 10 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.1%
4/79 • Number of events 4 • All events.
Site reported.
|
|
Vascular disorders
Bleeding Event
|
11.4%
9/79 • Number of events 10 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
3/79 • Number of events 3 • All events.
Site reported.
|
|
Blood and lymphatic system disorders
Electrolyte and/or CBC and platelet counts abnormal
|
6.3%
5/79 • Number of events 5 • All events.
Site reported.
|
|
Infections and infestations
Endocarditis
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
General disorders
Fever
|
5.1%
4/79 • Number of events 4 • All events.
Site reported.
|
|
Vascular disorders
Hematoma
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Vascular disorders
Hemorrhage requiring transfusion
|
2.5%
2/79 • Number of events 2 • All events.
Site reported.
|
|
Vascular disorders
Hemorrhagic event
|
3.8%
3/79 • Number of events 3 • All events.
Site reported.
|
|
Vascular disorders
Hypertension
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Vascular disorders
Hypotension
|
1.3%
1/79 • Number of events 2 • All events.
Site reported.
|
|
Infections and infestations
Infection (excluding endocarditis)
|
2.5%
2/79 • Number of events 4 • All events.
Site reported.
|
|
Nervous system disorders
Neurological Event (including TIA, stroke and psychomotor deficit)
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Injury, poisoning and procedural complications
Pain at catheterization site
|
2.5%
2/79 • Number of events 2 • All events.
Site reported.
|
|
Cardiac disorders
Paravalvular leak
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
3/79 • Number of events 3 • All events.
Site reported.
|
|
Injury, poisoning and procedural complications
Pulmonary artery perforation - rupture of RVOT conduit
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory complication
|
2.5%
2/79 • Number of events 2 • All events.
Site reported.
|
|
Nervous system disorders
Syncope
|
3.8%
3/79 • Number of events 4 • All events.
Site reported.
|
|
Cardiac disorders
Valve damage or dysfunction
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
Cardiac disorders
Valve stenosis
|
1.3%
1/79 • Number of events 1 • All events.
Site reported.
|
|
General disorders
Other
|
45.6%
36/79 • Number of events 90 • All events.
Site reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator will submit to Edwards all manuscripts or presentations authored by investigator and his/her collaborators which result from the Clinical Study at least thirty days prior to submission of the manuscript for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER