PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
NCT ID: NCT00294645
Last Updated: 2010-10-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
980 participants
INTERVENTIONAL
2004-04-30
2008-04-30
Brief Summary
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Detailed Description
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1. Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of AT/AF per day
2. Ventricular pacing that has increased by 30 percent (relative) since the last device interrogation
3. A sensed ventricular response of greater than 100 beats per minute (BPM) during atrial tachyarrhythmia for at least 20 percent of the time since the previous device interrogation
4. Runs of non-sustained ventricular tachycardia (NSVT) greater than 5 beats
5. New onset of AT/AF among patients with no history of AT/AF
6. Loss of atrial capture
7. Loss of ventricular capture
8. Increase in atrial pacing voltage threshold greater than 1 volt (V)
9. Increase in ventricular pacing voltage threshold greater than 1 volt (V)
10. \& 11. Significant change in atrial or ventricular lead impedance, defined as any of the following:
1. Less than 200 or greater than 2000 ohms (Ω)
2. Unstable lead impedance deemed to be clinically actionable
3. Greater than 50 percent change in lead impedance since last interrogation
12\. Elective Replacement Indicator (ERI)/Battery End of Life (EOL) indicators
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Transtelephonic monitoring at 2 month intervals
Transtelephonic monitoring (TTM)
TTM conducted at 2 month intervals. For patients with dual-chamber pacemakers, an in-office visit was required at 6 months (rather than TTM transmission for patients with single-chamber pacemakers). Follow-up frequency established to mimic best case standard of care when utilizing TTM for follow-up. A 12-month in-office visit completed the follow-up period.
Remote
Medtronic CareLink® Network remote pacemaker interrogation at 3 month intervals
Medtronic CareLink® Network
Remote pacemaker interrogation conducted at 3 month intervals. Follow-up frequency established to mimic best case standard of care when utilizing implantable cardioverter defibrillator (ICD) remote interrogation for follow-up. A 12-month in-office visit completed the follow-up period.
Interventions
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Transtelephonic monitoring (TTM)
TTM conducted at 2 month intervals. For patients with dual-chamber pacemakers, an in-office visit was required at 6 months (rather than TTM transmission for patients with single-chamber pacemakers). Follow-up frequency established to mimic best case standard of care when utilizing TTM for follow-up. A 12-month in-office visit completed the follow-up period.
Medtronic CareLink® Network
Remote pacemaker interrogation conducted at 3 month intervals. Follow-up frequency established to mimic best case standard of care when utilizing implantable cardioverter defibrillator (ICD) remote interrogation for follow-up. A 12-month in-office visit completed the follow-up period.
Eligibility Criteria
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Inclusion Criteria
* Patient agrees to complete all required follow-up transmissions and in-office visits
* Patient is capable of operating the TTM monitor and Medtronic CareLink monitor
Exclusion Criteria
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Cardiac Rhythm Disease Management Clinical Research
Principal Investigators
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PREFER Study Team
Role: STUDY_CHAIR
Medtronic
Locations
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Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Washington D.C., District of Columbia, United States
Ormond Beach, Florida, United States
Safety Harbor, Florida, United States
Springfield, Illinois, United States
Des Moines, Iowa, United States
Lafayette, Louisiana, United States
Bangor, Maine, United States
Glen Burnie, Maryland, United States
Takoma Park, Maryland, United States
Burlington, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Hattiesburg, Mississippi, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Great Falls, Montana, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Ocean City, New Jersey, United States
Paterson, New Jersey, United States
Towaco, New Jersey, United States
Voorhees Township, New Jersey, United States
Mineola, New York, United States
Raleigh, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Marion, Ohio, United States
Tulsa, Oklahoma, United States
Bend, Oregon, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Temple, Texas, United States
Tacoma, Washington, United States
Wauwatosa, Wisconsin, United States
Countries
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References
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Chen J, Wilkoff BL, Choucair W, Cohen TJ, Crossley GH, Johnson WB, Mongeon LR, Serwer GA, Sherfesee L. Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients. Trials. 2008 Apr 3;9:18. doi: 10.1186/1745-6215-9-18.
Crossley GH, Chen J, Choucair W, Cohen TJ, Gohn DC, Johnson WB, Kennedy EE, Mongeon LR, Serwer GA, Qiao H, Wilkoff BL; PREFER Study Investigators. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol. 2009 Nov 24;54(22):2012-9. doi: 10.1016/j.jacc.2009.10.001.
Other Identifiers
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701
Identifier Type: -
Identifier Source: org_study_id