PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Pacemaker Remote Follow-up Evaluation and Review

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).

Study Overview

• Status: Completed
• Conditions: Bradycardia; Arrhythmia
• Intervention / Treatment: Other: Transtelephonic monitoring (TTM); Other: Medtronic CareLink® Network

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

• Study Type: Interventional
• Enrollment (Actual): 980
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Ormond Beach, Florida, United States
    • Safety Harbor, Florida, United States
  • Illinois
    • Springfield, Illinois, United States
  • Iowa
    • Des Moines, Iowa, United States
  • Louisiana
    • Lafayette, Louisiana, United States
  • Maine
    • Bangor, Maine, United States
  • Maryland
    • Glen Burnie, Maryland, United States
    • Takoma Park, Maryland, United States
  • Massachusetts
    • Burlington, Massachusetts, United States
  • Michigan
    • Ann Arbor, Michigan, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Mississippi
    • Hattiesburg, Mississippi, United States
    • Jackson, Mississippi, United States
  • Missouri
    • Kansas City, Missouri, United States
    • St. Louis, Missouri, United States
  • Montana
    • Great Falls, Montana, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • Nevada
    • Reno, Nevada, United States
  • New Jersey
    • Ocean, New Jersey, United States
    • Paterson, New Jersey, United States
    • Towaco, New Jersey, United States
    • Voorhees, New Jersey, United States
  • New York
    • Mineola, New York, United States
  • North Carolina
    • Raleigh, North Carolina, United States
  • Ohio
    • Cleveland, Ohio, United States
    • Columbus, Ohio, United States
    • Dayton, Ohio, United States
    • Marion, Ohio, United States
  • Oklahoma
    • Tulsa, Oklahoma, United States
  • Oregon
    • Bend, Oregon, United States
  • Pennsylvania
    • Lancaster, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Wynnewood, Pennsylvania, United States
  • South Carolina
    • Columbia, South Carolina, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
    • Nashville, Tennessee, United States
  • Texas
    • Corpus Christi, Texas, United States
    • Houston, Texas, United States
    • Plano, Texas, United States
    • Temple, Texas, United States
  • Washington
    • Tacoma, Washington, United States
  • Wisconsin
    • Wauwatosa, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Transtelephonic monitoring at 2 month intervals	Other: 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.
Active Comparator: Remote; Medtronic CareLink® Network remote pacemaker interrogation at 3 month intervals	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One year post-enrollment
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	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	Compare time to diagnosis in Control and Remote arms	One year post-enrollment
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	One year post-enrollment
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	One year post-enrollment
Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months	Compare time to first diagnosis in Control and Remote arms	One year post-enrollment
Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months	Compare time to first diagnosis in Control and Remote arms	One year post-enrollment
Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months	Compare time to first diagnosis in Remote and Control arms	One year post-enrollment
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	One year post-enrollment
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	One year post-enrollment
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	One year post-enrollment
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	One year post-enrollment
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	One year post-enrollment

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Medtronic
• Investigators: Study Chair: PREFER Study Team, Medtronic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 20, 2006
• First Submitted That Met QC Criteria: February 20, 2006
• First Posted (Estimate): February 22, 2006

Study Record Updates

• Last Update Posted (Estimate): October 19, 2010
• Last Update Submitted That Met QC Criteria: October 1, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Diagnostic; Bradycardia; Remote Follow Up
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: 701