Clinical trial NCT00294645: PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
Official title: Pacemaker Remote Follow-up Evaluation and Review
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Arrhythmia
Keywords: Remote Follow Up
Diagnostic
Bradycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-02-22
Enrollment: 980
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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

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)

Primary outcomes:
measure: Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months
timeFrame: One year post-enrollment
Secondary outcomes:
measure: Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months
timeFrame: One year post-enrollment
measure: 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
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months
timeFrame: One year post-enrollment
measure: Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months
timeFrame: One year post-enrollment
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Washington
country: United States
state: District of Columbia
city: Ormond Beach
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Lafayette
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Glen Burnie
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Burlington
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Hattiesburg
country: United States
state: Mississippi
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Ocean
country: United States
state: New Jersey
city: Paterson
country: United States
state: New Jersey
city: Towaco
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Mineola
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Wauwatosa
country: United States
state: Wisconsin
Study officials:
affiliation: Medtronic
name: PREFER Study Team
role: STUDY_CHAIR
References:
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.
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.