Electrophysiology- RESPECT
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Trial Sponsor
Medtronic Cardiac Rhythm Disease Management
Principal Investigator
Luis Caceres, MD
Trial Name
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Purpose
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).
Eligibility
Genders Eligible for Study
Both
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.
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