Status:
COMPLETED
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrial Fibrillation
Tachycardia, Supraventricular
Eligibility:
All Genders
Phase:
NA
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 symptom...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00289289
Start Date
February 1 2004
End Date
July 1 2011
Last Update
August 8 2012
Active Locations (38)
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1
Little Rock, Arkansas, United States
2
Rancho Mirage, California, United States
3
San Diego, California, United States
4
Yuba City, California, United States