Trial Outcomes & Findings for PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy (NCT NCT00146848)
NCT ID: NCT00146848
Last Updated: 2011-12-28
Results Overview
The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association \[NYHA\] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.
COMPLETED
PHASE4
1742 participants
From randomization (6-weeks) through 12-month visit
2011-12-28
Participant Flow
Enrollment began on November 8, 2004, was completed on December 21, 2007, with study follow-up commencing January 30, 2009. This trial was conducted at institutional settings throughout the United States and Australia.
All patients with successful system implants were programmed to DDD-40 (atrial rate support above 40 bpm; limited atrial pacing) for the first 6-weeks of the trial. Randomization (1:1:1 allocation) occurred after patients had reached the 6-week visit and continued to meet all of the eligibility criteria for the trial.
Participant milestones
| Measure |
DDD-40
Atrial Tracking (atrial rate support above 40 bpm)
|
DDD-70
Atrial Rate Support (atrial rate support above 70 bpm)
|
DDDR-40
Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
|
|---|---|---|---|
|
Pre-randomization
STARTED
|
1742
|
0
|
0
|
|
Pre-randomization
COMPLETED
|
1433
|
0
|
0
|
|
Pre-randomization
NOT COMPLETED
|
309
|
0
|
0
|
|
Post-randomization
STARTED
|
475
|
488
|
470
|
|
Post-randomization
COMPLETED
|
437
|
441
|
431
|
|
Post-randomization
NOT COMPLETED
|
38
|
47
|
39
|
Reasons for withdrawal
| Measure |
DDD-40
Atrial Tracking (atrial rate support above 40 bpm)
|
DDD-70
Atrial Rate Support (atrial rate support above 70 bpm)
|
DDDR-40
Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
|
|---|---|---|---|
|
Pre-randomization
Death
|
19
|
0
|
0
|
|
Pre-randomization
Lost to Follow-up
|
70
|
0
|
0
|
|
Pre-randomization
Physician Decision
|
8
|
0
|
0
|
|
Pre-randomization
Protocol Violation
|
172
|
0
|
0
|
|
Pre-randomization
Withdrawal by Subject
|
40
|
0
|
0
|
|
Post-randomization
Lost to Follow-up
|
12
|
15
|
12
|
|
Post-randomization
Withdrawn
|
26
|
32
|
27
|
Baseline Characteristics
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
Baseline characteristics by cohort
| Measure |
DDD-40
n=475 Participants
Atrial Tracking (atrial rate support above 40 bpm)
|
DDD-70
n=488 Participants
Atrial Rate Support (atrial rate support above 70 bpm)
|
DDDR-40
n=470 Participants
Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
|
Total
n=1433 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
67.3 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
486 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
310 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
947 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From randomization (6-weeks) through 12-month visitPopulation: This analysis is intention to treat (ITT) in terms of patient's being analyzed according to their randomized group. Last observation carried forward (LOCF) method was used for missing NYHA and global assessment measures at 12 months.
The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association \[NYHA\] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.
Outcome measures
| Measure |
DDD-40
n=437 Participants
Atrial Tracking (atrial rate support above 40 bpm)
|
DDD-70
n=441 Participants
Atrial Rate Support (atrial rate support above 70 bpm)
|
DDDR-40
n=431 Participants
Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
|
|---|---|---|---|
|
Clinical Composite Score
Worsened
|
123 participants
|
112 participants
|
117 participants
|
|
Clinical Composite Score
Improved
|
230 participants
|
235 participants
|
229 participants
|
|
Clinical Composite Score
Unchanged
|
84 participants
|
94 participants
|
85 participants
|
SECONDARY outcome
Timeframe: From randomization (6-weeks) through 12-month visitPopulation: Quality of Life was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups.
Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.
Outcome measures
| Measure |
DDD-40
n=348 Participants
Atrial Tracking (atrial rate support above 40 bpm)
|
DDD-70
n=370 Participants
Atrial Rate Support (atrial rate support above 70 bpm)
|
DDDR-40
n=357 Participants
Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
|
|---|---|---|---|
|
Change in Quality of Life
|
-2.97 units on a scale
Standard Deviation 24.18
|
-3.27 units on a scale
Standard Deviation 22.77
|
-4.46 units on a scale
Standard Deviation 25.43
|
SECONDARY outcome
Timeframe: From randomization (6-weeks) through 12-month visitPopulation: Physical activity was assessed using the Physical Activity Scale for the Elderly and was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups. Postive values for changes denote improvements.
Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.
Outcome measures
| Measure |
DDD-40
n=339 Participants
Atrial Tracking (atrial rate support above 40 bpm)
|
DDD-70
n=362 Participants
Atrial Rate Support (atrial rate support above 70 bpm)
|
DDDR-40
n=348 Participants
Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
|
|---|---|---|---|
|
Change in Self Assessed Physical Activity
|
12.45 units on a scale
Standard Deviation 78.62
|
22.62 units on a scale
Standard Deviation 88.86
|
25.69 units on a scale
Standard Deviation 92.41
|
Adverse Events
DDD-40
DDD-70
DDDR-40
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DDD-40
n=475 participants at risk
Atrial Tracking (atrial rate support above 40 bpm)
|
DDD-70
n=488 participants at risk
Atrial Rate Support (atrial rate support above 70 bpm)
|
DDDR-40
n=470 participants at risk
Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
|
|---|---|---|---|
|
Cardiac disorders
Cardiovascular related
|
16.8%
80/475 • Number of events 124 • Adverse event data were collected from randomization (6-weeks) through the 12-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
18.2%
89/488 • Number of events 125 • Adverse event data were collected from randomization (6-weeks) through the 12-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
16.2%
76/470 • Number of events 117 • Adverse event data were collected from randomization (6-weeks) through the 12-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
General disorders
Non-device, non-lead, non-procedure or non-cardiovascular related AE "other"
|
13.5%
64/475 • Number of events 82 • Adverse event data were collected from randomization (6-weeks) through the 12-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
8.8%
43/488 • Number of events 58 • Adverse event data were collected from randomization (6-weeks) through the 12-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
9.6%
45/470 • Number of events 54 • Adverse event data were collected from randomization (6-weeks) through the 12-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER