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Completed

NCT Number: NCT00294645

PREFER (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).

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Key information

Conditions

Bradycardia Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Disease Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scottsdale, Arizona, United States

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About this study

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
  • Elective Replacement Indicator (ERI)/Battery End of Life (EOL) indicators

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transtelephonic monitoring (TTM)

Other

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

Other

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 outcomes

  1. Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months

    Time frame: One year post-enrollment

    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 outcomes

  1. Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events

    Time frame: One year post-enrollment

    Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other

  2. Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Remote and Control arms

  3. 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

    Time frame: One year post-enrollment

    Compare time to diagnosis in Control and Remote arms

  4. Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months

    Time frame: One year post-enrollment

    Compare time to diagnosis in Control and Remote arms

  5. Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Control and Remote arms

  6. Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Control and Remote arms

  7. Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Control and Remote arms

  8. Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Remote and Control arms

  9. Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Remote and Control arms

  10. Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Control and Remote arms

  11. Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Control and Remote arms

  12. Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Control and Remote arms

  13. Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months

    Time frame: One year post-enrollment

    Compare time to first diagnosis in Control and Remote arms

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

Pacemaker Remote Follow-up Evaluation and Review

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2006
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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