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| ID | Type | Description | Link |
|---|---|---|---|
| PEGASUS |
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This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
PEGASUS CRT is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (CRT-D) device programmed to DDD-70 or DDDR-40 compared to a CRT device programmed to DDD-40 in heart failure patients. The effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating. A sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDD-40 | Active Comparator | DDD-40 for this trial is the comparator arm. Even though patients are receiving a CRT-D device, atrial support pacing in this arm will be limited as the device will not pace unless the rate falls below 40 bpm. |
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| DDDR-40 | Active Comparator | DDDR-40 programming will initiate atrial support pacing if the rate falls below 40 bpm or if atrial support is needed in response to increased activity. |
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| DDD-70 | Active Comparator | Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices | Device | All subjects in this trial receive the same device. For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Composite Score | 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. | From randomization (6-weeks) through 12-month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | 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. | From randomization (6-weeks) through 12-month visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David O. Martin, MD, MPH | The Cleveland Clinic | Principal Investigator |
| John Day | Utah Heart Clinic, LDS Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Hospital | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17174627 | Background | Martin DO, Stolen KQ, Brown S, Yu Y, Christie C, Doshi SK, Smith JM, Gold MR, Day JD. Pacing Evaluation-Atrial SUpport Study in Cardiac Resynchronization Therapy (PEGASUS CRT): design and rationale. Am Heart J. 2007 Jan;153(1):7-13. doi: 10.1016/j.ahj.2006.10.013. | |
| 22830441 | Derived | Martin DO, Day JD, Lai PY, Murphy AL, Nayak HM, Villareal RP, Weiner S, Kraus SM, Stolen KQ, Gold MR. Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1317-25. doi: 10.1111/j.1540-8167.2012.02402.x. Epub 2012 Jul 25. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | DDD-40 | Atrial Tracking (atrial rate support above 40 bpm) |
| FG001 | DDD-70 | Atrial Rate Support (atrial rate support above 70 bpm) |
| FG002 | DDDR-40 | Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-randomization |
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| Post-randomization |
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| ID | Title | Description |
|---|---|---|
| BG000 | DDD-40 | Atrial Tracking (atrial rate support above 40 bpm) |
| BG001 | DDD-70 | Atrial Rate Support (atrial rate support above 70 bpm) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Quality of Life | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | From randomization (6-weeks) through 12-month visit |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DDD-40 | Atrial Tracking (atrial rate support above 40 bpm) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular related | Cardiac disorders | Systematic Assessment |
Lack of longer-term follow-up. Single blind design where investigator could be aware of treatment assignment. Two conservative atrial support pacing modes; results should not be extended to substantially more atrial pacing and higher heart rates.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kira Stolen | Clinical Affairs | 1 800 CARDIAC | cshd@bsci.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Change in Self Assessed Physical Activity |
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. |
| From randomization (6-weeks) through 12-month visit |
| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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| BG002 | DDDR-40 | Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing) |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG002 | DDDR-40 | Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing) |
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| Primary | Clinical Composite Score | 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. | 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. | Posted | Number | participants | From randomization (6-weeks) through 12-month visit |
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| Secondary | Change in Self Assessed Physical Activity | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | From randomization (6-weeks) through 12-month visit |
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| 0 |
| 0 |
| 129 |
| 475 |
| EG001 | DDD-70 | Atrial Rate Support (atrial rate support above 70 bpm) | 0 | 0 | 119 | 488 |
| EG002 | DDDR-40 | Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing) | 0 | 0 | 112 | 470 |
| Non-device, non-lead, non-procedure or non-cardiovascular related AE "other" | General disorders | Systematic Assessment |
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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.
| Title | Measurements |
|---|---|
|
| Worsened |
|
| 0.80 |
| 95 |
| No |
| Superiority or Other |
Compare the difference in the changes in physical activity scores between groups using a t-test.
To adjust for multiple comparisons, an alpha level of 0.025 should be used to deem significance.
| t-test, 2 sided |
| 0.04 |
| Mean Difference (Final Values) |
| -13.24 |
| Standard Error of the Mean |
| 6.55 |
| 2-Sided |
| 95 |
| -26.11 |
| -0.37 |
| No |
| Superiority or Other |