Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 400
- Locations
- 38
- Primary Endpoint
- Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month
Time Frame: 6-months (per Intervention)
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
Secondary Outcomes
- Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist(6 months (per Intervention))
- Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)(6 months (per Intervention))
- Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden(6 months (per Intervention))