N/A
N=400
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Atrial Fibrillation · Tachycardia, Supraventricular · Arrhythmia · Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT00289289 ↗Enrolled (actual)
400
Serious AEs
4.8%
Results posted
Aug 2012
Primary outcome: Primary: Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month — 2.0; 1.8 Episodes per subject per month — p=0.629
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention Pacing Features (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month |
2.0; 1.8 | 0.629 |
| SECONDARY Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist |
12.0; 13.0 | 0.165 |
| SECONDARY Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock) |
2.1; 3.3 | 0.603 |
| SECONDARY Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden |
4.0; 4.1 | 0.394 |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00289289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.