PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
Primary Purpose
Bradycardia, Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transtelephonic monitoring (TTM)
Medtronic CareLink® Network
Sponsored by
About this trial
This is an interventional treatment trial for Bradycardia focused on measuring Remote Follow Up, Diagnostic, Bradycardia
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patient is an immediate candidate for an implantable cardioverter defibrillator (ICD)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control
Remote
Arm Description
Transtelephonic monitoring at 2 month intervals
Medtronic CareLink® Network remote pacemaker interrogation at 3 month intervals
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events
Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other
Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months
Compare time to first diagnosis in Remote and Control arms
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
Compare time to diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months
Compare time to diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months
Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months
Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months
Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months
Compare time to first diagnosis in Remote and Control arms
Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months
Compare time to first diagnosis in Remote and Control arms
Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months
Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months
Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months
Compare time to first diagnosis in Control and Remote arms
Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months
Compare time to first diagnosis in Control and Remote arms
Full Information
NCT ID
NCT00294645
First Posted
February 20, 2006
Last Updated
October 1, 2010
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00294645
Brief Title
PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
Official Title
Pacemaker Remote Follow-up Evaluation and Review
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
The Clinically Actionable Events (CAE) were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The defined events are:
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
Ventricular pacing that has increased by 30 percent (relative) since the last device interrogation
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
Runs of non-sustained ventricular tachycardia (NSVT) greater than 5 beats
New onset of AT/AF among patients with no history of AT/AF
Loss of atrial capture
Loss of ventricular capture
Increase in atrial pacing voltage threshold greater than 1 volt (V)
Increase in ventricular pacing voltage threshold greater than 1 volt (V)
& 11. Significant change in atrial or ventricular lead impedance, defined as any of the following:
Less than 200 or greater than 2000 ohms (Ω)
Unstable lead impedance deemed to be clinically actionable
Greater than 50 percent change in lead impedance since last interrogation
12. Elective Replacement Indicator (ERI)/Battery End of Life (EOL) indicators
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Arrhythmia
Keywords
Remote Follow Up, Diagnostic, Bradycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
980 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Transtelephonic monitoring at 2 month intervals
Arm Title
Remote
Arm Type
Active Comparator
Arm Description
Medtronic CareLink® Network remote pacemaker interrogation at 3 month intervals
Intervention Type
Other
Intervention Name(s)
Transtelephonic monitoring (TTM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Medtronic CareLink® Network
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months
Description
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.
Time Frame
One year post-enrollment
Secondary Outcome Measure Information:
Title
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events
Description
Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months
Description
Compare time to first diagnosis in Remote and Control arms
Time Frame
One year post-enrollment
Title
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
Description
Compare time to diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months
Description
Compare time to diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months
Description
Compare time to first diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months
Description
Compare time to first diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months
Description
Compare time to first diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months
Description
Compare time to first diagnosis in Remote and Control arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months
Description
Compare time to first diagnosis in Remote and Control arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months
Description
Compare time to first diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months
Description
Compare time to first diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months
Description
Compare time to first diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
Title
Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months
Description
Compare time to first diagnosis in Control and Remote arms
Time Frame
One year post-enrollment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patient is an immediate candidate for an implantable cardioverter defibrillator (ICD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PREFER Study Team
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
Scottsdale
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Arizona
Country
United States
City
Little Rock
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Arkansas
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United States
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Washington
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District of Columbia
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United States
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Ormond Beach
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Florida
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Safety Harbor
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Springfield
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Illinois
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Des Moines
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Lafayette
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Bangor
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Glen Burnie
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Takoma Park
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Burlington
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Ann Arbor
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Minneapolis
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Hattiesburg
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Jackson
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Kansas City
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St. Louis
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Great Falls
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Omaha
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Reno
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Nevada
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Ocean
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Paterson
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Towaco
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Voorhees
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New Jersey
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Mineola
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New York
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City
Raleigh
State/Province
North Carolina
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Cleveland
State/Province
Ohio
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United States
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Columbus
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Dayton
State/Province
Ohio
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Marion
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Ohio
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Tulsa
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Oklahoma
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Bend
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Oregon
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Lancaster
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Philadelphia
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Wynnewood
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Columbia
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South Carolina
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Chattanooga
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Tennessee
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United States
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Nashville
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Tennessee
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Corpus Christi
State/Province
Texas
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United States
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Houston
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Texas
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United States
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Plano
State/Province
Texas
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United States
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Temple
State/Province
Texas
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United States
City
Tacoma
State/Province
Washington
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United States
City
Wauwatosa
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18387185
Citation
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.
Results Reference
background
PubMed Identifier
19926006
Citation
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.
Results Reference
derived
Learn more about this trial
PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
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