Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
NCT ID: NCT00289289
Last Updated: 2012-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2004-02-29
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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On-Off
Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
Intervention Pacing Features
Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
Off-On
Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
Intervention Pacing Features
Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
Non-randomized
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.
No interventions assigned to this group
Interventions
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Intervention Pacing Features
Intervention pacing features (atrial rate stabilization algorithm, atrial preference pacing algorithm, post mode switch overdrive pacing algorithm) in the pacemaker.
Eligibility Criteria
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Inclusion Criteria
* 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 atrial fibrillation due to a reversible cause, i.e. electrolyte imbalance.
* Subjects who are current or immediate implantable cardioverter defibrillator (ICD) recipients.
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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RESPECT Team
Role: STUDY_CHAIR
Medtronic
Locations
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Little Rock, Arkansas, United States
Rancho Mirage, California, United States
San Diego, California, United States
Yuba City, California, United States
Colorado Springs, Colorado, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Urbana, Illinois, United States
Indianapolis, Indiana, United States
Cedar Rapids, Iowa, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Takoma Park, Maryland, United States
Springfield, Massachusetts, United States
Minneapolis, Minnesota, United States
Clifton, New Jersey, United States
Morristown, New Jersey, United States
Albuquerque, New Mexico, United States
Mineola, New York, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Spartanburg, South Carolina, United States
Amarillo, Texas, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Richmond, Virginia, United States
Morgantown, West Virginia, United States
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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217
Identifier Type: -
Identifier Source: org_study_id