PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
Pacemaker Remote Follow-up Evaluation and Review
1 other identifier
interventional
980
1 country
45
Brief Summary
The purpose of the study is to compare remote pacemaker follow-up to current standard of care follow-up. The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the Medtronic Carelink® Network (Remote arm) versus patients who are followed via routine office visits augmented by transtelephonic monitoring (TTM)(Control arm).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2004
Longer than P75 for not_applicable
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 20, 2006
CompletedFirst Posted
Study publicly available on registry
February 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
October 19, 2010
CompletedOctober 19, 2010
October 1, 2010
4 years
February 20, 2006
April 1, 2009
October 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months
Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.
One year post-enrollment
Secondary Outcomes (13)
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events
One year post-enrollment
Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months
One year post-enrollment
Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months
One year post-enrollment
Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months
One year post-enrollment
Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months
One year post-enrollment
- +8 more secondary outcomes
Study Arms (2)
Control
ACTIVE COMPARATORTranstelephonic monitoring at 2 month intervals
Remote
ACTIVE COMPARATORMedtronic CareLink® Network remote pacemaker interrogation at 3 month intervals
Interventions
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 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
You may qualify if:
- Patient has been previously implanted with a dual-chamber or single-chamber EnPulse®, Kappa 900®, or Adapta® device
- 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
You may not qualify if:
- Patient is an immediate candidate for an implantable cardioverter defibrillator (ICD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (45)
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Ormond Beach, Florida, United States
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Safety Harbor, Florida, United States
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Springfield, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
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Lafayette, Louisiana, United States
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Bangor, Maine, United States
Unknown Facility
Glen Burnie, Maryland, United States
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Takoma Park, Maryland, United States
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Burlington, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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Hattiesburg, Mississippi, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Omaha, Nebraska, United States
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Reno, Nevada, United States
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Ocean City, New Jersey, United States
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Paterson, New Jersey, United States
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Towaco, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Mineola, New York, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Marion, Ohio, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Temple, Texas, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Wauwatosa, Wisconsin, United States
Related Publications (2)
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.
PMID: 18387185BACKGROUNDCrossley 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.
PMID: 19926006DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CRDM Clinical
- Organization
- Medtronic CRDM
Study Officials
- STUDY CHAIR
PREFER Study Team
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 20, 2006
First Posted
February 22, 2006
Study Start
April 1, 2004
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
October 19, 2010
Results First Posted
October 19, 2010
Record last verified: 2010-10