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The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of breath, dizziness, and others).
The purpose of the study was to confirm the AT500 intervention pacing effectiveness data previously seen in the ASPECT clinical trial and to gather additional data to understand the effectiveness of the intervention pacing features. Specifically, the goal of the trial is to demonstrate a reduction in frequency in symptomatic atrial tachycardia/atrial fibrillation recurrence with the intervention pacing features in patients with a pacing indication and a history of atrial tachyarrhythmias with atrial pacing leads located in the region of Bachmann's Bundle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-Off | Active Comparator | Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period. |
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| Off-On | Active Comparator | Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period. |
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| Non-randomized | No Intervention | Subjects that did not have device recorded episodes of atrial tachycardia/atrial fibrillation during the 3 month observation period post-implant did not qualify for randomization but were continued to be followed in the study. There were no programming requirements and symptom activations were not collected. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Pacing Features | Device | Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month | The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed | 6-months (per Intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist | The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RESPECT Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
At the 3-month post-implant follow-up visit, all implanted subjects with documented Atrial tachycardia/Atrial fibrillation episode(s) during the 3-month observation period were eligible for randomization. Subjects with no documented Atrial tachycardia/Atrial fibrillation episodes were followed as part of the non-randomized group.
The first study implant occurred on 13 February 2004 and the last study visit occurred on 10 November 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | On-Off | Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period. |
| FG001 | Off-On |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 months (per Intervention) |
| Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock) | The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF. | 6 months (per Intervention) |
| Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden | AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day. | 6 months (per Intervention) |
| Rancho Mirage |
| California |
| United States |
| San Diego | California | United States |
| Yuba City | California | United States |
| Colorado Springs | Colorado | United States |
| Jacksonville | Florida | United States |
| Lakeland | Florida | United States |
| Chicago | Illinois | United States |
| Decatur | Illinois | United States |
| Urbana | Illinois | United States |
| Indianapolis | Indiana | United States |
| Cedar Rapids | Iowa | United States |
| Louisville | Kentucky | United States |
| Owensboro | Kentucky | United States |
| Takoma Park | Maryland | United States |
| Springfield | Massachusetts | United States |
| Minneapolis | Minnesota | United States |
| Clifton | New Jersey | United States |
| Morristown | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Mineola | New York | United States |
| Charlotte | North Carolina | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Hershey | Pennsylvania | United States |
| Spartanburg | South Carolina | United States |
| Amarillo | Texas | United States |
| Austin | Texas | United States |
| Corpus Christi | Texas | United States |
| Fort Worth | Texas | United States |
| Salt Lake City | Utah | United States |
| Burlington | Vermont | United States |
| Richmond | Virginia | United States |
| Morgantown | West Virginia | United States |
| Edmonton | Alberta | Canada |
| Hamilton | Ontario | Canada |
| Kingston | Ontario | Canada |
| Sherbrooke | Quebec | Canada |
Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
| FG002 | Non-Randomized Group | Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | On-Off | Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period. |
| BG001 | Off-On | Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period. |
| BG002 | Non-Randomized Group | Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period |
| BG003 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month | The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed | Patient Assistant data which contained markers for symptomatic atrial tachycardia or atrial fibrillation episodes obtained from save-to-disk data was required from both randomized follow-up periods (3-9 months and 9-15 months) for the subject to be included in the primary ITT analysis. | Posted | Mean | Standard Deviation | Episodes per subject per month | 6-months (per Intervention) |
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| Secondary | Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist | The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed. | Of the 256 randomized subjects only 211 completed the AF symptom checklist at both the 9-month and 15-month visit. Since this was a crossover study, data from both visits was required for the subject to be included in the analysis | Posted | Median | Full Range | Scores on a scale | 6 months (per Intervention) |
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| Secondary | Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock) | The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF. | All randomized subjects with follow-up during intervention pacing feature programming period. | Posted | Mean | Standard Deviation | Months | 6 months (per Intervention) |
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| Secondary | Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden | AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day. | Of the 256 randomized to ON-OFF or OFF-ON programming, 225 had device data necessary for computing AT/AF burden in both randomized study periods. | Posted | Mean | Standard Deviation | hours per day | 6 months (per Intervention) |
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From enrollment through the 15-month study visit
Only serious adverse events when information reasonably suggested that a device had or may have caused the adverse event were collected.
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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 | On-Off | Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period. | 7 | 132 | 0 | 0 | ||
| EG001 | Off-On | Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period. | 8 | 124 | 0 | 0 | ||
| EG002 | Non-Randomized Group | Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period | 4 | 144 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RV Lead Dislodgement | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Other System Effect | General disorders | Medtronic Specific | Non-systematic Assessment |
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| RA Lead Dislodgement | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Atrial Fibrillation | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Atrial Fibrillation/Gastrointeritis | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Device Electrical Reset | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Dizziness | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Failure to Capture | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Hemo/pneumothorax | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Other Component Failure | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Pacemaker Syndrome | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Pocket Erosion | General disorders | Medtronic Specific | Non-systematic Assessment |
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| Pulmonary Edema | General disorders | Medtronic Specific | Non-systematic Assessment |
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| RV and RA Lead Dislodgement | General disorders | Medtronic Specific | Non-systematic Assessment |
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The effect of ON programming was not consistent across randomized study period, violating a key assumption of the cross-over study design.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jen Lahr | Medtronic CRDM Clinical | jen.lahr@medtronic.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013617 | Tachycardia, Supraventricular |
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Canada |
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A mean difference greater than zero indicates an average increase in atrial fibrillation/atrial tachycardia symptomatic episodes while the intervention pacing features were programmed ON versus OFF. |
| No |
| Superiority or Other |
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| Participants |
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