PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00294645
First received: February 20, 2006
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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).


Condition Intervention
Bradycardia
Arrhythmia
Other: Transtelephonic monitoring (TTM)
Other: Medtronic CareLink® Network

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pacemaker Remote Follow-up Evaluation and Review

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    Compare time to first diagnosis in Control and Remote arms

  • Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    Compare time to first diagnosis in Control and Remote arms

  • Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    Compare time to first diagnosis in Control and Remote arms

  • Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year post-enrollment ] [ Designated as safety issue: No ]
    Compare time to first diagnosis in Control and Remote arms


Enrollment: 980
Study Start Date: April 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294645

  Show 45 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
Study Chair: PREFER Study Team Medtronic
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic, Cardiac Rhythm Disease Management Clinical Research
ClinicalTrials.gov Identifier: NCT00294645     History of Changes
Other Study ID Numbers: 701
Study First Received: February 20, 2006
Results First Received: April 1, 2009
Last Updated: October 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Remote Follow Up
Diagnostic
Bradycardia

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Bradycardia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014