PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Medtronic

Status: Completed

Conditions: Bradycardia; Arrhythmia

Treatments: Other: Medtronic CareLink® Network; Other: Transtelephonic monitoring (TTM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294645

701

Details and patient eligibility

About

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).

Full 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

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

Enrollment: 980 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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980 participants in 2 patient groups

Control

Active Comparator group

Description:

Transtelephonic monitoring at 2 month intervals

Treatment:

Other: Transtelephonic monitoring (TTM)

Remote

Active Comparator group

Description:

Medtronic CareLink® Network remote pacemaker interrogation at 3 month intervals

Treatment:

Other: Medtronic CareLink® Network