Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)

Conditions
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Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia

Intervention / Treatment
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* Device: Intervention Pacing Features


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with fast and/or slow heartbeats who are in need of dual chamber pacing (pacing in both the atria and ventricles) as determined by their doctor. Subjects who have a history of occasional fast heartbeats originating from the upper heart chambers. Subjects who have experienced at least two symptomatic episodes of fast heartbeats three months prior to enrollment. Subjects that are expected to stay on the same heart medications during the length study. Exclusion Criteria: Subjects who have permanent (chronic) or persistent (not self-terminating) atrial fibrillation (fast heartbeats originating from the upper heart chambers). Subjects who have atrial fibrillation due to a reversible cause, i.e. electrolyte imbalance. Subjects who are current or immediate implantable cardioverter defibrillator (ICD) recipients.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: On-Off<br>Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period. | Device: Intervention Pacing Features<br>* Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.<br>|
| Active Comparator: Off-On<br>Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period. | Device: Intervention Pacing Features<br>* Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.<br>|
| No Intervention: Non-randomized<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Atrial Tachyarrhythmia, Arrhythmia, Bradycardia, Cardiac Pacemaker, IPG Indication, Pacing